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Post by lakers on Jun 11, 2017 3:15:49 GMT -5
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Post by Deleted on Jun 11, 2017 7:00:50 GMT -5
Perhaps Cipla should consider partnering with MannKind?
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Post by mnkdfann on Jun 11, 2017 9:33:55 GMT -5
FWIW, that happened last year. Any updates available? |
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Post by lakers on Jun 11, 2017 13:59:53 GMT -5
Cipla’s inhalable insulin fails to get approval for trials on Indian patients www.bullfax.com/?q=node-cipla’s-inhalable-insulin-fails-get-approval-trials-indRead more: mnkd.proboards.com/thread/8042/cipla-inhalable-insulin-approval-trials#ixzz4jimSKXhCMike gave a not-so-subtle hint, analogous to leaks by Comey:-). Cipla USA Inc., Inc., the US subsidiary of Cipla Limited, is the first Indian company to be approved by US FDA in 1985. Through a comprehensive partnership approach model, Cipla has been dedicated to providing access to medicines to US patients for over 30 years. The company has executed US partnerships and has commercialized products in the US. Cipla has supported the development of more than 170 ANDAs. Cipla has an active internal pipeline including several key respiratory products and other complex generics. Cipla launched its US label in January 2015. In September 2015, Cipla's UK arm, Cipla EU has entered into definitive agreements to acquire two US-based companies, InvaGen Pharmaceuticals Inc., and Exelan Pharmaceuticals Inc. Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India.[3][4][5] Belgium, Surrey in the European Union, Miami, Florida, in the United States and Cape Town in South Africa; with manufacturing facilities in Goa (eleven), Bengaluru (one), Baddi (one), Indore (one), Kurkumbh (one), Patalganga (one), and Sikkim (one), along with field stations in Delhi, Pune, and Hyderabad[6] and Durban, South Africa. Cipla primarily develops medicines to treat cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions. Cipla’s vision for the USA: US FDA approved drugs A global pharmaceutical company whose top priority is ensuring no patient shall be denied access to high quality & affordable medication and support. Cipla Limited is a global pharmaceutical company which uses technology and innovation to meet the everyday needs of all patients. For more than 70 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 150 countries. Our portfolio includes over 1500 products with 60 plus dosage forms across wide range of therapeutic categories. Cipla USA Inc., the US subsidiary of Cipla Limited, is based in Miami, FL. Our story in the US market started in 1984, when Cipla became the first Indian company to receive US FDA approval. Today in a tightly regulated environment, Cipla's 30 plus manufacturing facilities across India have been approved by major international regulatory agencies including US FDA, MHRA-UK, WHO, Department of Health-Canada, MCC – South Africa, ANVISA – Brazil, and PMDA – Japan. Cipla maintains world-class quality for its products and services across domestic and overseas markets, thereby ensuring that every patient has access to the best medicines in the world. cipla pharmaceutical companyThrough a comprehensive partnership model approach, Cipla has been dedicated to providing access to medicines at an affordable price for over 30 years in the US. The company has executed over 20 US partnerships and currently has commercialized products in the US. Cipla has supported the development of more than 170 ANDAs. Cipla USA brings a variety of technologies to the US markets in order to keep its ongoing commitment to provide access to high quality complex products at affordable prices. Cipla aims to continue to bring its wealth of pharmaceutical experience to develop innovative products and advanced drug delivery systems to offer meaningful healthcare solutions to patients in the US. www.ciplausa.com/about-us |
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Post by lakers on Jun 11, 2017 14:11:28 GMT -5
the article was just too relevant not to in-line here lest it's deleted. BRIC expansion has started. A was trade marked in R. CIPLA’S INHALABLE INSULIN FAILS TO GET APPROVAL FOR TRIALS ON INDIAN PATIENTS Mon, 12/05/2016 - 16:27 EDT - The Economic Times RDF10 MUMBAI: Drug maker Cipla’s plan of developing a pump-delivered inhalable form of insulin has suffered a setback with an expert committee denying it permission to conduct trials on Indian patients. The panel has said the company’s preliminary data on safety and efficacy of the trial drug is insufficient. Cipla had based its application to the panel on the bioequivalence studies with Exubra, an inhalation drug and device combination that was being marked by Pfizer. Exubra was withdrawn from the market in 2007 due to slowdown in sales mainly because of issues revolving around product design. In November, the Subject Expert Committee — a group comprising experts in diverse fields of endocrinology and metabolism-—met and noted, "The firm (Cipla) has presented BA/BE (bioavailability/bioequivalence) study data and requested for phase IV study which is not acceptable and not scientifically justified with respect to inhaled insulin." Cipla declined to comment on the development. A year ago, Cipla’s application was examined by the same committee. It was directed to establish the safety, efficacy and dose finding study (phase I and II) before carrying out phase III study. That apart, Cipla was asked to provide safety and toxicological data from experimental/animal studies. "The firm should also carry out the coefficient of variation and stability of the device intended to be used for delivering of inhaled/powder insulin," the committee had then said in its report. A veteran in clinical research told ET the chances of Cipla getting a green signal appear slim given the issues related to studies to establish safety, efficacy and immunogenicity of the product in the new formulation. However, he said, carrying out large-scale studies and improving on the product design would enable Cipla to prove that it has bettered the safety and technology profile of the product. Although drug makers have explored technological disruptions to deliver insulin in forms other than needles and bring in convenience to the patients, those have met with little success. It was not just Pfizer’s Exubra that was junked. More recently, French drug maker Sanofi ended its deal with US-based Mannkind which had developed Afrezza. The product could not reach a scale due to lower-than-expected response from prescribers. Novo Nordisk, the biggest insulin maker in the world, recently dropped its project on oral insulin. Instead, it is focusing on a non-insulin drug that can be had as a tablet. Those failures, however, do not take away from Cipla’s capabilities in developing products using the inhalation technology. www.bullfax.com/?q=node-cipla’s-inhalable-insulin-fails-get-approval-trials-ind |
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Post by mnkdfann on Jun 11, 2017 14:18:57 GMT -5
It's 2016 news, though. What's happened since? Do we know?
Is Cipla's product dead in the water or are they just readying a new application for any day now?
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Post by lakers on Jun 11, 2017 14:25:36 GMT -5
It's 2016 news, though. What's happened since? Do we know? Is Cipla's product dead in the water or are they just readying a new application for any day now? They explore other venues... |
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Post by brotherm1 on Jun 11, 2017 16:20:29 GMT -5
CIPLA 4.4 billion $ market cap = 3 1/2 x the size of AMGN
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Post by mnholdem on Jun 11, 2017 16:54:40 GMT -5
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Post by mnkdfann on Jun 12, 2017 9:39:20 GMT -5
And fwiw Cipla's 445B market cap in INR, converts to about 6.9B USD.
So Amgen's market cap is much much larger.
All figures taken from yahoo finance.
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Post by mnkdfann on May 9, 2018 8:49:06 GMT -5
Perhaps Cipla should consider partnering with MannKind? Boo-yah! |
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Post by mnholdem on May 9, 2018 9:54:07 GMT -5
Excerpt from post by lakers (above):
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India.[3][4][5] Belgium, Surrey in the European Union, Miami, Florida, in the United States and Cape Town in South Africa; with manufacturing facilities in Goa (eleven), Bengaluru (one), Baddi (one), Indore (one), Kurkumbh (one), Patalganga (one), and Sikkim (one), along with field stations in Delhi, Pune, and Hyderabad[6] and Durban, South Africa. Cipla primarily develops medicines to treat cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.
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