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Post by lakers on Jan 30, 2016 11:27:58 GMT -5
Mnkd removed slide #9 from their original presentation that included 12 drug candidates they were researching for Technosphiere. Why doesn't Mannkind have that slide now available for viewing under the"Spot Light" Link, and why did Mannkind quickly remove the original JP Morgan link that contained it ? Treprostinil+PDE5 Inhibitor PAH Partnership TBA next on 2/3/16? screencast.com/t/c2xjgEILYpHakan said during the 3Q Call. "As I mentioned last quarter, we were pleased to welcome the new Chief Medical Officer leading the development team. And in the last couple of months, our development group has been very busy moving ahead with the formulation work on the pulmonary hypertension program, as well as lining up a dozen more product candidates with commercial potential. And there is no way we can fund all of this potential activity, so we have also initiated discussions with several firms that could participate in product development as strategic or financial partners." With input from Kevinmik.
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Post by lakers on Jan 28, 2016 23:50:09 GMT -5
Scientists pursue a diabetes drug that also fights obesity Scientists pursue a diabetes drug that also fights obesity Scientists at the University at Buffalo and California Institute for Biomedical Research are developing a diabetes therapy based on a modified version of the hormone oxyntomodulin. In this illustration, the modified hormone (top) binds to a glucagon-like peptide-1 receptor (bottom). A chemical linker (top, in turquoise) helps the molecule keeps its helical shape — an innovation that could improve the potential treatment's effectiveness. Credit: Yulin Tian Insulin helps patients with Type 2 diabetes regulate their blood sugar, but the treatment is also associated with weight gain—an unwanted and unhealthy side effect. To address that problem, scientists at the University at Buffalo and California Institute for Biomedical Research (Calibr) in La Jolla, California, are working to develop a therapy that could enable patients to control glucose levels while also losing weight. The treatment the researchers are developing is based on oxyntomodulin, a hormone that performs two important biological functions: First, it helps to keep glucose levels low by helping to increase insulin production. Second, the hormone encourages weight loss in part by facilitating processes that reduce food intake and increase the body's expenditure of energy. "On its own, oxyntomodulin has a short half-life. It's broken down quickly in the body, which means that patients would need to take it often and use high doses for it to work as a pharmaceutical," says Qing Lin, a chemistry professor in UB's College of Arts and Sciences. "We've modified the hormone's structure in a way that enhances its potency and enables it to survive in the body for longer periods of time, which allows for less frequent and more effective dosing." On Jan. 4 in ACS Chemical Biology, the researchers report that they have created several new versions of oxyntomodulin, including two that decreased blood glucose levels considerably in mice. Mice that received one of the two new compounds after ingesting glucose saw their glucose levels fall by 40 to 45 percent more than mice that received a placebo treatment. The two compounds also survived longer inside the animals than oxyntomodulin as it's found in nature. Lin was a senior author on the paper, along with Weijun Shen at Calibr. Lin has founded a startup, Transira Therapeutics, to further explore the potential therapy. Keeping oxyntomodulin in a helix In the body, oxyntomodulin regulates glucose levels and facilitates weight loss by binding to and activating two cellular receptors: the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R). Oxyntomodulin performs its job best when it's in a certain helix conformation, but like many other peptide hormones, oxyntomodulin usually shifts between different shapes, including various helices and a random coil. Lin and his colleagues use a clever chemistry trick to help oxyntomodulin keep its helical shape. Their patented method is called chemical cross-linking. It involves engineering an oxyntomodulin molecule to include two groups of chemicals containing an amino acid called cysteine on different parts of the molecule, and then using a chemical linker to fasten those two groups together to make the molecule rigid. In cultured cells, cross-linked oxyntomodulin molecules were extremely effective in activating GCGR and GLP-1R, Lin and his colleagues reported in ACS Chemical Biology. The helical molecules are also harder for enzymes to break down, which helps the molecules survive longer in the body. More information: Avinash Muppidi et al. Design of Potent and Proteolytically Stable Oxyntomodulin Analogs, ACS Chemical Biology (2016). DOI: 10.1021/acschembio.5b00787 m.phys.org/news/2016-01-scientists-pursue-diabetes-drug-obesity.html[Mnkd hasbe n working on Oxyntomodulin for a long time. It filed patent and presented paper at Conf]
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Post by lakers on Jan 28, 2016 15:38:40 GMT -5
I confirm that Andrea Leone-Bay was laid off as part of the restructuring on 9/23/15. She was quickly hired as Chief Scientist by RLS in Oct 2015. This showed that RLS has been in talk w/ MNKD way back.
The 2/3/16 SH CC by Matt, Ray gonna be interesting re: runway extension.
Has anyone emailed ir@mannkindcorp.com asking about 24-mo runway extension and Afrezza divestiture ?
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Post by lakers on Jan 27, 2016 13:06:22 GMT -5
lakers... I sure would be curious how negotiations on price would occur if Al is investing more. If there were other arms length investors that Matt negotiated with and Al simply had prior commitment for $X at whatever the negotiated price, that might pass muster for fair to shareholders. But, in all honesty, Al probably doesn't have a lot of spare cash to throw at MNKD. He certainly isn't anywhere near a billionaire these days. I did that calculation some time ago based on what he was listed at Forbes (when last he was listed) and his known stake in MNKD and how much that has fallen. It could encourage other investors if Al is participating in a round. One wrinkle is if Mnkd successfully sells Afrezza to a BP, then that will determine how much equity stake at what set price for big investors. Apparently, Vulcan Capital is very interested in TS. I wouldn't be surprised if they and Al take an equity stake under one condition: Mnkd has to divest Afrezza. I agree that for Afrezza to succeed, it needs to be owned by a deep-pocket BP. IMHO, Mgmt and BoD know that. With $1.6B tax loss credit, if TS becomes successful after Afrezza is sold, this is a great investment for big investors.
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Post by lakers on Jan 27, 2016 12:29:22 GMT -5
I stated in another thread yesterday my comments from January 5th. It would be a very good thing to sell the company. We need new energy, investment and direction. Everybody wants Afrezza to be a blockbuster winner that can only happen if the company has a very strong partner or new owner. I am sure they board of directors know this and that Al Mann does too. Ultimately being owned by a bigger pharma will enable the proper marketing. I see a bidding war for the company if we are truly exploring a sale situation. I own shares from 10.50 down to the depths of recent pricing. A sale at $5.00 gets many of us whole. The company has value if it survives and selling the company without further dilution is best for all including Al. $10.00 would be nice and $20.00 would be a big winner for most of us.
Not trying to be a buzz killer but I am a realist/businessman. Better to see this happen than a bankruptcy and killing of our investment in this company. A week ago, I got a confirmation there would be a full BoD meeting scheduled on 2/18/16. This meeting is not to certify 10-K or 10-Q. Other than that, I don't know what the meeting is for. It could be to decide on some strategic options presented. Really like Harryx1's pics. IMHO, options include letting big investors including Al acquiring an equity stake at a set price which should put a floor under pps, selling Afrezza to a large co. To focus on TS.
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Post by lakers on Jan 27, 2016 12:01:10 GMT -5
www.latimes.com/business/la-fi-mannkind-sale-report-20160126-story.htmlNews that MannKind is working with investment bankers on strategic options — including a possible sale — was reported Tuesday by Reuters, citing unnamed sources. “I can't comment on anything like that,” said Matt Pfeffer, MannKind's chief executive and chief financial officer. “The attorneys are quite emphatic about it.” In an interview with The Times this week, Pfeffer said MannKind is looking for new sales and distribution partners, rethinking the marketing strategy for Afrezza, working to get the drug approved for sale in markets outside of the United States, continuing to develop other inhalable drugs and licensing its technology to other drug developers. Lloyd Greif, chief executive of downtown L.A. investment bank Greif & Co., said all the activity that Pfeffer mentioned suggests the company is scrambling to stay afloat — and that it is likely considering any option, including a sale, that would stave off bankruptcy. “It conveys a sense of urgency. No question the company's back is up against the wall and they're going to look at any and all reasonable options,” Greif said. Ahmed Enany, chief executive of trade group Southern California Biomedical Council, said any company in MannKind's situation would consider a transaction. He also noted that choosing its finance chief to lead the company “made sense.” “Putting him at the helm might help the company explore options, including a sale,” Enany said.
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Post by lakers on Jan 26, 2016 16:08:23 GMT -5
Post from Yahoo: finance.yahoo.com/news/insulin-drug-maker-mannkind-explores-195258110.html
NEW YORK, Jan 26 (Reuters) - Mannkind Corp, the U.S. maker of inhaled insulin drug Afrezza, is exploring strategic options, including the sale of itself, people familiar with the matter said on Tuesday.
Mannkind is working with investment bankers on options, the people said, asking not to be identified because the deliberations are confidential. Mannkind did not respond to requests for comment.
Mnkd has $1.6B tax loss carry forward and $725 remaining milestone bonus it can potentially get from Sanofi via settlement. If Mnkd is acquired for $2.3B, $5.5/share, the acquirer still gets the whole company for free. Got it?
Dearfield forced DNDN to sell the co.
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Post by lakers on Jan 25, 2016 22:44:33 GMT -5
Subject: Is it too late to join Afrezza pediatric study? Hi Bao-khanh, Regarding the Afrezza pediatric study, have you finished recruiting and started trial for Phase one yet? When will Phase 1 finish? When will Phase 2 start and finish? What dosing at what time do you expect? For example do you need more Afrezza units per unit of basal drug? Do you inhale 10 mins after starting a meal? What CGM do you use? If it's not too late, I can refer my relative to join the trial. Now that Sanofi terminates partnership with Mannkind, who gonna manage and fund Phase 1 and 2? Thanks, RE: Is it too late to join Afrezza pediatric study? Reply at 4:13 PM 1/25/16 I apologize for the delay in response. Those definitely good question. We are still currently still recruiting for our cohort I (ages 13-17). As far as starting for cohort II (ages 8-12) that is dependent on the data that we have collected for our cohort I. As far as dosing, it depends on the child's carb to insulin ratio. Currently Afrezza's insulin dosing is equivalent to that of the rapid acting insulin drug 1:1 ratio of how you would usually dose with your rapid/short-acting insulin. As far as basal, the dosing should not change when enrolled in the study. For the CGM, the model that is being used is the G4 however the data will be blinded therefore the child will not be able to see the data on the CGM. As far as the partnership study will still continue its course for recruitment. We are always happy to answer any questions you or your relative may have. Thank you for your interest in our study! Sincerely, Bao-Khanh Tran, BS Professional Research Assistant for Dr. Wadwa Barbara Davis Center for Childhood Diabetes University of Colorado School of Medicine Mail Stop F527 1775 Aurora Court Aurora, CO 80045 Phone: 303-724-8095 bao-khanh.tran@ucdenver.edu clinicaltrials.gov/ct2/show/NCT02527265?term=439065&rank=2
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Post by lakers on Jan 25, 2016 14:54:04 GMT -5
www.psychiatryadvisor.com/alzheimers-disease-and-dementia/inhaled-insulin-improves-memory-dementia-treatment/article/430731/August 05, 2015 Inhaled Insulin Eyed As a Dementia Treatmentthe Psychiatry Advisor take: Insulin delivered through the nasal cavity may improve memory in those suffering from dementia. William Banks, MD a professor of internal medicine and geriatrics at the University of Washington School of Medicine and a physician at the Veteran’s Administration Puget Sound Medical Center, and colleagues made the discovery based on a mouse model. In an object recognition test, which depends a mouse's natural curiosity for new things, old mice do not remember whether objects they are presented to play with are new or old. But, after a single dose of intranasal insulin, they can remember which objects they have seen before, the researchers reported in the Journal of Alzheimer’s Disease. Although hundreds of trials are being conducted on Alzheimer’s, few are looking at insulin and how it affects cognition. Banks said there are probably 100 intranasal compounds that could be tested for treating Alzheimer’s. “Before this study, there was very little evidence of how insulin gets into the brain and where it goes,” Banks said in a statement. “We showed that insulin goes to areas where we hoped it would go.” Researchers at the UW Medicine, Veteran's Administration Puget Sound and Saint Louis University have made a promising discovery that insulin delivered high up in the nasal cavity goes to affected areas of brain with lasting results in improving memory. The findings were published online July 30 in the Journal of Alzheimer's Disease. Importantly, researchers also found that insulin does not go into the bloodstream when delivered intranasally, a major concern in the medical community because it would lower blood sugar levels. Additionally, repeated doses increased insulin's efficacy in aiding memory. Paul Allen Takes On Alzheimer's With $7M In New Research Grants JUL 14, 2015 @ 08:00 AM www.forbes.com/sites/arleneweintraub/2015/07/14/paul-allen-takes-on-alzheimers-with-7m-in-new-research-grants/#28f02a675eb3Paul Allen, philanthropist and co-founder of Microsoft MSFT +0.46%, has devoted many millions of dollars to unlocking the mysteries of the brain, and today he’s taking on a new challenge: Alzheimer’s disease. The Paul G. Allen Family Foundation, launched by the tech mogul and his sister, Jody Lynn, in 1988, has awarded $7 million in grants to five teams of researchers who are working on new ways of combating the degenerative brain disease. The new grants were largely driven by Allen’s desire to overcome the hurdles plaguing the field of Alzheimer’s drug development, says Judy Lytle, manager of medical research for the organization’s life sciences portfolio. Clinical trials of experimental therapies to treat the disease have suffered a 99.6% failure rate. There have been a number of high-profile failures in recent years, including bapineuzumab from Pfizer PFE +0.00%, Johnson & Johnson JNJ +0.63%, and Elan ELN +% Pharmaceuticals in 2012. Allen, who has often spoken about his mother’s battle against Alzheimer’s, has a policy of thinking outside the box when it comes to funding medical research, Lytle says. The most recent tranche of money, for example—which was awarded under an ongoing program called the Allen Distinguished Investigator (ADI) grants—went to teams that include both neurology experts and scientists who have other areas of expertise, such as immunology. These projects could provide a deeper understanding of what’s going on in the brain before Alzheimer’s symptoms develop, Lytle says—and that could be essential to developing better treatments for patients. Although a handful of Alzheimer’s drugs have made it onto market, they merely lessen the symptoms and delay the progression of the disease. “If we understand that progression, maybe we can actually intervene at the appropriate time. But the first step is to understand what’s happening there.” The Alzheimer’s program is the latest milestone in Allen’s plan to improve the world’s understanding of the brain. In May, the Allen Institute for Brain Science, which is backed by $500 million of his money, launched a cell types database containing information on 240 neurons. Funding from philanthropists like Allen can be an important bridge for medical researchers who hope to ultimately win support from deep-pocketed investors like Big Pharma companies looking for fresh research to fill their pipelines. Federal funding for Alzheimer’s research currently stands at about $586 million a year, according to the Alzheimer’s Association, which recently celebrated a Senate Appropriations Committee proposal to boost that amount by 60%. That’s good news, to be sure, but cross-disciplinary teams such as the ones Allen is supporting might have trouble accessing that money, Lytle says. Allen hopes to close that funding gap. “ Paul is very interested in Alzheimer’s disease research—it hits close to home for him,” she says. “We’re in the process of putting together a 10-year plan for the topics we want to go after, and given that interest, I can see a role for neurodegenerative disease and Alzheimer’s specifically.” The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)clinicaltrials.gov/ct2/show/NCT01767909ClinicalTrials.gov Identifier: NCT01767909 Last updated: January 14, 2016 Sponsor: University of Southern California Collaborators: National Institute on Aging (NIA) Alzheimer's Therapeutic Research Institute Wake Forest School of Medicine Information provided by (Responsible Party): Paul Aisen, University of Southern California Purpose An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family members, and society is enormous, and is predicted to grow exponentially as the median population age increases. Current FDA-approved therapies are modestly effective at best. This study will examine a novel therapeutic approach using intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful, information gained from the study has the potential to move INI forward rapidly as a therapy for AD. The study will also provide evidence for the mechanisms through which INI may produce benefits by examining key cerebral spinal fluid (CSF) biomarkers and hippocampal/entorhinal atrophy. These results will have considerable clinical and scientific significance, and provide therapeutically-relevant knowledge about insulin's effects on AD pathophysiology. Growing evidence has shown that insulin carries out multiple functions in the brain, and that insulin dysregulation may contribute to AD pathogenesis. This study will examine the effects of intranasally-administered insulin on cognition, entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12 months of treatment with INI compared to placebo, subjects will improve performance on a global measure of cognition, on a memory composite and on daily function. In addition to the examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4) allele carriage predict treatment response. In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months, following an open-label period of 6 months where all participants will be given active drug. The study uses insulin as a therapeutic agent and intranasal administration focusing on nose to brain transport as a mode of delivery.Technosphere nasal inhaler Gen2 was registered with FDA 4/20/2015imgur.com/Ti7xJrjSome infos here are gathered from madog365 on YMB.
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Post by lakers on Jan 24, 2016 13:25:10 GMT -5
Marsie - I'm with you and well said. The cash issue is daunting but I would think it very likely to have been discussed already within the context of the TS deal. It's in RLS interest for Mnkd to be solvent at a minimum through the tech transfer. Don't recall when that exactly is but my logic is that gives a fairly decent runway for making another deal and of course increase scripts. I recall a license deal where we actually even revised the deal and stepped in with cash to protect our interests. However, I think the terms in this deal coupled with any other deals and/or increased sales will get us well into 2017 imo. I agree that RLS wouldn't sign a deal if Mnkd couldn't assure them of its own survival for at least a few years. Note that RLS is backed by some prominent entity. Vulcan Capital crossed my mind ? Mnkd can't fool them about its runway. Why waste time with a company about to go BK? I heard of how Mnkd proved to RLS it wouldn't fold in a few years. Although I can't verify that 100%, hope Matt will soon. Perhaps that's why Matt wanted to meet investors after full BoD meeting 2/18 and before ER 2/29? "We can confirm that the company is funded by an important investor group, supported by prominent business leaders in the Seattle area. Alfred Mann is not an investor or in any way affiliated with Receptor. MannKind did significant diligence in regards to Receptor and its financial backers, and came away quite impressed." Another Seattle VC crossed my mind is: Robert Nelsen, co-founder of Seattle-based venture-capital firm Arch Venture Partners, which controls stakes worth about $1 billion in nearly a half dozen companies pursuing immunotherapy and other cancer treatments. Arch owns about $470 million in shares of Juno, a company Arch co-founded, as well as $78 million of bluebird. “I have been creating biotech companies for 28 years and this is the first one where the jaded doctors who have seen everything and have lost hope are shaking their heads in amazement,” said Mr. Nelsen, a managing director at Arch, which manages more than $2 billion.
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Post by lakers on Jan 23, 2016 13:08:43 GMT -5
I always wished Mnkd diversified by entering the largest Pharmacy mkts: RA, MS, chronic pain. Now that RLS is likely backed by some of the most successful VCs, I am quite content to see SH value increase in the future. Volume based 12-15% royalty is huge compared to semiconductor which normally has 2% royalty. Al put all eggs in one basket, which was not a good strategy. It was all or nothing. Al should have diversified more. For such successful VCs, they would not let RLS fail or mismanaged. VCs control BoD and Advisory Board. Check out the huge, lucrative RA, MS. mnkd.proboards.com/thread/4986/agreement-mannkind-products
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Post by lakers on Jan 22, 2016 22:27:12 GMT -5
Microsoft co-founder builds biotech legacy with $500M neuroscience odyssey www.fiercebiotech.com/story/microsoft-co-founder-builds-biotech-legacy-500m-neuroscience-odyssey/2012-09-18Allen lieutenant David Capobianco, who took a seat on Plains’ board, touted the buyout as a “new direction” for Vulcan, which is known for investments in technology, real estate development, life sciences and financial services. Its current portfolio includes companies like online realty Redfin, biotech Juno Therapeutics and DreamWorks, the movie company. www.seattletimes.com/seattle-news/environment/paul-allen-was-key-investor-in-pipeline-company-behind-calif-spill/New Cancer Technology Gives Investors a Shot in the Arm Bristol-Myers Squibb Co.'s Yervoy melanoma treatment is among those immunotherapy drugs fueling red-hot interest in the sector and giving new hope in the fight against cancer. ENLARGE Bristol-Myers Squibb Co.'s Yervoy melanoma treatment is among those immunotherapy drugs fueling red-hot interest in the sector and giving new hope in the fight against cancer. Photo: Bristol-Myers Squibb/Bloomberg News By Gregory Zuckerman and Ron Winslow Feb. 22, 2015 2:03 p.m. ET George Soros, Michael Milken and David Bonderman are among marquee investors benefiting from early bets on a red-hot sector: young companies developing drugs that fight cancer by using the body’s immune system. Interest in the nascent approach, known as immunotherapy, has taken off following the success of Yervoy and Opdivo, a pair of drugs developed by giant Bristol-Myers Squibb Co. The treatments could generate $8.5 billion in annual revenue by 2020, Credit Suisse predicts, or more than half the New York company’s 2014 revenue of $15.9 billion. Hopes that fledgling companies will repeat and extend upon those advances are behind the recent share-price gains in Juno Therapeutics Inc., Kite Pharma Inc. and bluebird bio Inc. Their treatments, which take a different approach than Bristol-Myers’s, haven’t yet reached the market. “It’s clearly something new and it won’t be smooth sailing,” said Arie Belldegrun, Kite’s chairman and chief executive. “But if we can deliver what we promise, for the first time you won’t talk about remission, you can even talk about cure of cancer.” Earlier this month, Standard & Poor’s released a report naming five cancer immunotherapy agents among its top 10 drug prospects for 2015, underscoring growing enthusiasm for the strategy. Drugs made the list for their likely blockbuster sales potential as well as their probable impact on individual companies. No such drugs were included on its previous list in 2009. More companies are gaining “insights into underlying biology plus an understanding of biological systems that should transform the treatment of many extremely serious diseases,” said James E. Flynn, managing partner at Deerfield Management Co., an investment firm betting on the area. Among companies fueling current interest, only Bristol-Myers and Merck & Co. have had immunotherapy drugs approved by the U.S. Food and Drug Administration. For many of the smaller-cap companies, it will be a year or more before studies help clarify the benefits, risks and market potential of their treatments. Shares of Juno, which is developing therapies for leukemias and lymphomas, ended Friday’s trading at $45.52, following a December initial public offering at $24. Kite Pharma has soared to $62.80 from $28 since the beginning of October. Bluebird bio, driven more by advances by gene-therapy drugs than in immunotherapy, has climbed to $93.32 from $39 since early December. The three companies’ treatments are complex, likely to be expensive and cause severe side effects for some patients; none has yet been approved. But the strategy has shown dramatic results in leukemia and other blood cancers in early trials and researchers are racing to find ways to extend their use to other cancers. Indeed, researchers world-wide are working on various types of immunotherapy treatments, as well as strategies to combine them with existing treatments to tackle all kinds of cancer and extend their benefits to more patients. Mr. Bonderman, a founder of TPG Capital, is Kite’s fourth-largest shareholder and a board member, with over 6% of the company’s stock from an early, personal investment, according to FactSet. He has seen his holdings soar to about $145 million in value. Another early investor, hedge-fund veteran Donald Sussman, founder of Paloma Partners Management, holds a Kite stake worth about $100 million, according to regulatory filings. Representatives of Messrs. Bonderman and Sussman declined to comment. George Soros’s Soros Fund Management owns about 1.7% of Kite Pharma Inc.’s shares. ENLARGE George Soros’s Soros Fund Management owns about 1.7% of Kite Pharma Inc.’s shares. Photo: European Pressphoto Agency The firm that manages George’s Soros’s wealth, Soros Fund Management, is Kite’s 11th-largest holder. It owns about 1.7% of the company’s stock after purchasing the shares at less than $30 each last summer, according to filings. A spokesman declined to comment. Michael Milken also was an early investor in the company, said Mr. Belldegrun. A spokesman for Mr. Milken, who declined to confirm the investment, said the former junk-bond king’s “more than four decades of philanthropic work in medical research and public health has given him a deep understanding of the potential for lifesaving advances.” Deerfield Management owns about 4% of the shares of bluebird, according to the most recent filings, while Steve Cohen’s Point72 Asset Management LP owns nearly 2% of the shares. A spokesman for Point72 didn’t comment. Amazon.com Inc. founder Jeff Bezos and Microsoft Corp. co-founder Paul Allen are investors in Juno, says Robert Nelsen, co-founder of Seattle-based venture-capital firm Arch Venture Partners, which controls stakes worth about $1 billion in nearly a half dozen companies pursuing immunotherapy and other cancer treatments. Arch owns about $470 million in shares of Juno, a company Arch co-founded, as well as $78 million of bluebird. “I have been creating biotech companies for 28 years and this is the first one where the jaded doctors who have seen everything and have lost hope are shaking their heads in amazement,” said Mr. Nelsen, a managing director at Arch, which manages more than $2 billion. A spokesman for Mr. Allen confirmed his investment in Juno. A spokesman for Amazon.com declined to comment. Pension funds and venture-capital funds also are among those riding immunotherapy investments higher. The Alaska Permanent Fund Corp. was an early investor in Juno and controls a nearly 30% stake in the company worth about $1.1 billion. The state investment fund has yet to cash out any shares. Bristol and others working on immunotherapy drugs, including Merck, Roche Holding AG , AstraZeneca PLC and Novartis AG , are so large the financial impact of their immunotherapy drugs could be diluted by other businesses. That is why investors are bidding up smaller companies. Not all the immunotherapy news has been upbeat, though: Dendreon Corp., whose prostate cancer vaccine Provenge was hailed as the first immunotherapy at its approval in 2010, foundered amid limited efficacy, marketing gaffes, and better rival medicines. Dendreon is expected to be sold this month under bankruptcy court supervision to Valeant Pharmaceuticals International Inc. for $495 million. The intense interest in immunotherapy, an idea that dates back to the 19th century, has emerged from a key discovery researcher James Allison made in the mid-1990s. Dr. Allison, now the head of immunology at MD Anderson Cancer Center in Houston, discovered a way of releasing a natural brake on the immune system. Dr. Allison’s work paved the way for the development of Bristol-Myers’s Yervoy drug, which was approved in 2011 and was the first drug ever shown to improve survival in patients with advanced melanoma. “Our understanding of the immune system, and how it interacts with cancer, has grown dramatically,” says Dr. Jill O’Donnell-Tormey, chief executive and director of scientific affairs at the Cancer Research Institute, which funds immunotherapy research. Write to Gregory Zuckerman at gregory.zuckerman@wsj.com and Ron Winslow at ron.winslow@wsj.com www.wsj.com/articles/new-cancer-technology-gives-investors-a-shot-in-the-arm-1424631798
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Post by lakers on Jan 22, 2016 12:47:50 GMT -5
Hakan said they worked w/ some major portfolio management company. Inflamarory disorder means Rheumatoid Arthritis. Neurologic disease means Multiple Sclerosis. 9:01 am Mannkind enters into a collaboration and license agreement with a newly formed entity, Receptor Life Sciences (MNKD) : The co announced that it has entered into a collaboration and license agreement with a newly formed entity, Receptor Life Sciences, Inc., pursuant to which multiple inhaled therapeutic products will be developed to explore their potential to treat conditions such as chronic pain, neurologic diseases and inflammatory disorders. Under the terms of the agreement, MannKind will perform initial formulation studies and will work with Receptor to develop inhaled formulations of certain undisclosed compounds. MannKind will also transfer manufacturing technology to the licensee, who will be responsible for manufacturing and commercialization activities. The parties will collaborate on the clinical development of investigational products, with Receptor being responsible for all development costs. MannKind will be eligible to receive development and commercialization milestones of up to $102.25 million as well as mid-single to low double-digit royalties on net sales of product. Spasticity refers to feelings of stiffness and a wide range of involuntary muscle spasms (sustained muscle contractions or sudden movements). It is one of the more common symptoms of MS. Spasticity may be as mild as the feeling of tightness of muscles or may be so severe as to produce painful, uncontrollable spasms of extremities, usually of the legs. Spasticity may also produce feelings of pain or tightness in and around joints, and can cause low back pain. Although spasticity can occur in any limb, it is much more common in the legs. Spasticity is a condition in which certain muscles are continuously contracted. This contraction causes stiffness or tightness of the muscles and can interfere with normal movement, speech, and gait. Spasticity is usually caused by damage to the portion of the brain or spinal cord that controls voluntary movement. Who is the licensing agreement with? The licensing agreement is between MannKind and Receptor Life Sciences, Inc., an independent company, not affiliated with MannKind. The company is private and newly formed under this name. We can confirm that the company is funded by an important investor group, supported by prominent business leaders in the Seattle area. Alfred Mann is not an investor or in any way affiliated with Receptor. MannKind did significant diligence in regards to Receptor and its financial backers, and came away quite impressed. But the underlying investors, for good reasons of their own, need not and choose not to disclose their involvement at this time. How will Technosphere technology be used by the licensee? Technosphere technology is to be used as a vehicle to deliver regulated doses of a proprietary compound to treat a variety of medical conditions, including chronic pain, spasticity and inflammatory diseases such as rheumatoid arthritis. What are the benefits of using MannKind’s technology for the licensee? Technosphere’s value proposition is the immediate delivery of a consistent and precise dosage of the prescribed amount of an active therapeutic compound, while reducing unwanted side effects. In addition, MannKind’s inhalers are convenient, discreet and easy-to-use from patients’ perspective as well as being a robust and low-cost delivery system from a manufacturing perspective. What are the financial terms of the agreement? Under the terms of the licensing agreement, Mannkind is eligible to receive up to $102.25 million in milestone payments. Additionally, MannKind will receive royalties paid on sales of the product. Those royalties are tiered based on sales volumes, and range from the mid-single digits at lower volumes to low double digits at higher volumes. Is the agreement exclusive in any way? The agreement is exclusive only to the compounds used by the licensee, which are proprietary to them in any case. It does not prevent us from entering into other licensing agreements with other companies, even in the same therapeutic area, so long as they use different active compounds. [As I had said licensee wanted to develop MS and Rheumatoid Athritis - 2 huge mkts. Paul Allen, MSFT founder, might be one of investors. Gates Foundation might be another.] www.mannkindcorp.com/Collateral/Documents/English-US/TS%20licensing%20FAQ.pdf
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Post by lakers on Jan 21, 2016 12:14:46 GMT -5
Brilliant move by Mnkd who is laying a nest of lucrative golden eggs. Look at large rev mkt opportunity below. Unbelievable!! As we discussed last week, traditional drug price inflation tends to be hit or miss depending on the therapeutic indication. However, when it comes to specialty indications, which are more complex and rare than traditional ones, there's no mistaking the trend: prescription costs are rising very fast. Fda FbImage source: U.S. Food and Drug Administration. These specialty drug classes cost an arm and a leg According to the 2014 Drug Trend Report from Express Scripts (NASDAQ:ESRX), the nation's largest pharmacy-benefits manager, specialty therapies for the top 10 spendiest therapeutic indications rose by a whopping 25.2% in 2014, while utilization rates increased by a modest 5.8%. Increased cancer drug usage, stemming from longer survival times, was a driver of utilization, whereas price growth can be pinpointed, in many instances, to individual drugs. Express Scripts determines whether costs rose or fell on a year-over-year basis by utilizing its per member, per year spend, or PMPY spend. Based on its findings, the following specialty therapy classes are by far the costliest to consumers. Inflammatory conditions Topping the list, according to Express Scripts' PMPY spend, is inflammatory conditions, where overall drug use rose by 8.5%, and unit costs rose close to 16%. This was the sixth consecutive year that inflammatory conditions took the "honor" as the most expensive drug class per Express Scripts. Humira Image source: AbbVie. What's the culprit? It looks to be a combination of a growing number of rheumatoid arthritis cases, as well as two primary therapies holding a vast majority of market share. AbbVie's Humira and Amgen's Enbrel together hold more than 80% of the inflammatory condition market share. Enbrel is currently on pace for $5 billion in sales, whereas Humira could be on pace for a record year of more than $13 billion. With little in the way of established competition, these two titans can raise their prices on an almost as-needed basis. Something worth watching here is the imminent loss of patent exclusivity on Humira at the end of 2016 and the eventual introduction of non-branded competition. It's possible that the inflammatory condition class could see cost cuts in the near future with Humira's dominance ending, but we're still a little more than a year away from that happening. Multiple sclerosis Sporting a PMPY spend of $52.36, multiple sclerosis therapies are the second-costliest specialty drug class, per Express Scripts. Although a mere 0.1% of the members in its network use MS drugs, the average prescription cost is over $4,500 due to the lack of generic drugs in this space. Year-over-year costs rose close to 10%. Copaxone Image source: Teva Pharmaceutical. There are a number of big players in MS, such as Teva Pharmaceutical (NYSE:TEVA) with its new longer-acting version of Copaxone. It'll be interesting to see how successful Teva is in transitioning patients over to the new extended formulation considering the prior-generation formulation is now off patent. For now, Copaxone maintains a commanding lead with nearly 30% market share, but expect this share to shift when Express Scripts updates the data next year. If there is a therapy to rival Copaxone, it's Biogen's (NASDAQ:BIIB) Tecfidera, a $3 billion-plus annual drug that costs about $55,000 per year. At the end of 2014, Tecfidera nearly had 20% market share in the MS space, and it sports such a favorable safety profile compared to competing therapies Gilenya and Aubagio that it'll likely hold onto its commanding market share for years to come. Biogen is among the leading researchers in MS, and its therapies will more than likely go a long way to determining pricing in this indication in the coming years. Oncology Personally, I was shocked this wasn't higher up on the list, but oncology drugs rank third in total PMPY spend at $41.64. Usage in this space rose by 8.9%, while costs jumped almost 12%. Oncology usage in Express Scripts' network is slightly lower than MS drug usage, but prescription costs in this indication average almost $6,200. Revlimid Image source: Celgene. Express Scripts points out that patients living and responding longer has helped drive oncology drug demand higher. Drug developers' focus on specialized cancer therapies, such as immunotherapies, is expected to play a major role in driving costs higher over the long run, too. Newly-approved immunotherapies such as Keytruda and Opdivo bring annual wholesale costs of $150,000 and $143,000 to the table. Insurers are almost certainly working out discounts relative to these wholesale costs, but these are expenses that the average American is going to struggle to afford. Celgene's (NASDAQ:CELG) Revlimid, a drug used as a primary first- and second-line treatment for multiple myeloma, held 10.8% of all oncology drug market share in Express Scripts' network of patients. With Revlimid being examined in eight other ongoing studies and already boasting a price tag near $100,000 per year, it's no wonder that Celgene's lead product is on pace for between $5.6 billion and $5.7 billion in sales this year. Hepatitis C Finally, it should come as no surprise that hepatitis C shot up the cost ranks among specialty diseases to No. 4 on Express Scripts' list with a PMPY spend of $37.95. Overall demand for HCV medicine rose 76% in 2014, while prices jumped a staggering 667%. No, there's not a misplaced number or decimal point there -- that's six hundred and sixty-seven percent! Sovaldi Image source: Gilead Sciences. If you want to point the finger, look no further than Gilead Sciences (NASDAQ:GILD). The approval of Sovaldi in 2013 and Harvoni in 2014 introduced two once-daily pills that came with price tags of $1,000 per day and $1,125 per day, respectively. Taking into account the average treatment timeframe of 12 weeks (some patients can qualify for as little as eight weeks of treatment, while others need up to 24 weeks), patients and their insurers are staring down $84,000 or $94,500 in total treatment costs. Of course, Sovaldi and Harvoni also offer unparalleled convenience and efficacy compared to prior-generation HCV therapies. Prior therapies, such as ribavirin and interferon, came with unpleasant side effects that included, but weren't limited to, flu-like symptoms, anemia, and rashes. Plus, cure rates prior to Sovaldi's approval were in the 50% to 80% range. Sovaldi and then Harvoni eliminated many of those unpleasant side effects, and most importantly led to a 90%-plus HCV clearance rate in nearly all clinical studies. As long as Gilead maintains its convenience and efficacy lead in the HCV space, expect its price to remain high. With the exception of inflammatory conditions, it's unlikely that consumers are going to see any relief in specialty drug prices anytime soon. For investors in most specialty drug developers that's great news, but for consumers it could mean opening up their pocketbooks ever wider. Read more: mnkd.proboards.com/thread/3827/teva-partner-expiring-copaxone-blockbust#ixzz3xtrQ9BJ7
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Post by lakers on Jan 21, 2016 12:07:49 GMT -5
Humira (Adalimumab) Humira is made by the pharmaceuticals giant AbbVie (NYSE:ABBV) and is approved for the treatment of, among other diseases, rheumatoid arthritis. The drug was made to inhibit production of TNF, or tumor necrosis factor, because TNF can cause severe inflammation and can impair the mobility of limbs and joints. Sales of Humira for full-year 2013 totaled a whopping $5.2 billion in the U.S. alone, a sales increase of nearly 18% year-over-year. The drug is taken by injection either by syringe or by injection pen usually weekly or biweekly in a new injection site every time. Pfizer (NYSE:PFE) has developed an oral form of the drug called Xeljanz, but a combination of sluggish sales and rejection by European regulatory authorities who questioned the drugs benefit-risk profile have taken a lot of the air out of the potential for the drug. Xeljanz causes side effects that Humira does not cause, so even the fact that it's taken orally does not convince many to use it. The opportunity is still open for a non-injected therapy to come in and steal market share from Humira, which is expected to see peak annual sales of $11.2 billion in 2016. Additionally, the rheumatoid arthritis market is expected to grow to $18.2 billion in 2023. Technosphere could be used to create an inhaled TNF inhibitor treatment that could compete with Humira for the sizable market that AbbVie's drug now dominates. The process would be simple: create a formulation with Technosphere particles and monoclonal antibodies that bind to and inhibit the TNF protein, and get FDA approval. Now I mean simple in theory, because actually making the formulation and getting passed regulatory hurdles is anything but simple. But the potential is there, and MNKD could benefit greatly from either creating this inhaled TNF inhibitor treatment itself or by licensing out Technosphere to another company that wants to try and develop the treatment. #2 Neulasta (Pegfilgrastim) Neulasta is a drug that patients take while undergoing chemotherapy, and the injection is taken once every chemotherapy cycle, which varies depending on the type of cancer and the patient. Specifically, Neulasta stimulates the bone marrow to produce more white blood cells to help fight off infection because chemotherapy leaves the immune system weak and vulnerable. The drug is produced by Amgen (NASDAQ:AMGN) and achieved sales of $3.5 billion for full-year 2013. Though sales growth has been slightly decreasing, Neulasta is the 9th best selling drug in the world. There are currently no non-injectable alternatives to Neulasta, leaving the market wide open to an inhaled treatment to gain some market share. The same argument I made for Humira can be made here: there is a large market opportunity, a need for a non-injected treatment and a company with the technology to create an alternative treatment. This all translates into a great opportunity for a Technosphere drug. #3 Copaxone (Glatiramer acetate) Copaxone was developed by Teva Pharmaceutical (NYSE:TEVA) to treat multiple sclerosis (MS), an inflammatory disease that affects the nerve cells. The drug is thought to reduce the progression of the disease, which causes disability by affecting nerves in the spinal cord and elsewhere. For full-year 2013, the drug generated sales of $4.3 billion, only a 1% increase year-over-year. Now, I don't know if you caught this, but sales of Copaxone are higher than #2 on this list, Neulasta. This is because Teva's best-selling drug is struggling with a lot of competition from both oral versions of the drug and generics, and Copaxone sales are expected to tumble 56% by 2016. However, the market opportunity for MS drugs is so large (the global MS market is projected to be $18.3 billion by 2018) that an inhaled MS treatment could carve out a good amount of market share. Read more: mnkd.proboards.com/thread/3694/flolan-migrained-imitrex-antiematic-zofran?page=3#ixzz3xtpkvCGc
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