PHARMA LITERATI

New Delhi: In a setback to major domestic pharma companies like Cipla, Torrent, Emcure, Alkem, the Delhi High Court has granted an injunction restraining them from selling a medicine used for prevention and treatment of thromboembolic diseases, the patent for which is held by Bristol-Myers Squibb (BMS). BMS filed its claims for patent infringement in Delhi HC, arguing that its anticoagulant product, Apixaban, is patented till September 2022. The drug was granted a patent in 2011. BMS, along with partner Pfizer, has been selling the drug used in the prevention and treatment of blood clots under the brand name Eliquis. The US firm stated that it came to know on December 6 that Cipla was planning to launch the generic version of Apixaban under the probable brand name Apigy. BMS carried out an extensive market survey in Delhi to ascertain whether Cipla’s product was launched in the market or not, and it was revealed that the product was not available in the domestic market. ...

Expert panel denies co permission to conduct trials on Indian patients 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 Exubra was withdrawn from the market in 2007 due to slowdown in sales mainly because of issues revolving around product design.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 BABE (bioavailability bioequivalence) study data and requested for phase IV study which is not acceptable and not scientifically justified with respe...

Therapeutic proteins (biosimilars) manufactured from natural sources and providing solutions for several unmet clinical needs are the next big thing in India. Adoption, growing investment and deal making in the global arena has got several Indian companies tuning in to biosimilars, reports The Pharma Letter’s India correspondent. Though the high price of biologic therapies is a great burden on healthcare costs globally and a majority of patients in India still cannot afford these drugs, Indian drug majors are stepping up investments to tap the growing opportunities overseas. While Cipla recently signed a memorandum of understanding to set up South Africa's first biosimilars manufacturing facility at a cost of nearly $91 million, Intas Pharma is gearing up for US approval for its Neulasta (pegfilgrastim) biosimilar this year. Amgen’s Neulasta is the company's second largest selling white blood cell boosting medicine, and reportedly brought in sales of $1.15 bill...

Calling for in-licensing system for patented and monopoly drugs developed abroad, Cipla chairman Y.K. Hamied said the company will continue its efforts to offer patients affordable medicines. Drug companies are facing a tough environment due to the government bringing more products under the price control policy as also tightening of registration procedure that has impacted time to market newer products, Cipla chairman Y.K. Hamied has said. “ The environment for the domestic pharma companies remains challenging with more products coming under price control, and other pressures such as government legislation to ban certain fixed dose combination drugs ,” Hamied told shareholders at the company’s annual general meeting (AGM), as per a regulatory filing on Thursday. Moreover, with the tightening of new product registration procedures, the approval time to market newer products has also been significantly impacted, he added. “ We do hope that the government will look into so...

Cipla, ranked third in the $17-billion Indian pharmaceutical market after Sun Pharma and Abbott, is setting its eyes on reaching a billion dollar sales mark, backed by new drug launches from its own research labs and a slew of partnerships with multinational and Indian drug firms. On a moving annual total basis, Cipla's India sales rose 8.6% to `5,033 crore in August, according to the AIOCD PharmaTrac data. Its market share stood at 4.9% compared to Sun Pharma's 8.7% and Abbott's 6.23% during the same period. Umang Vohra, the newly designated managing director of Cipla , told ET Now that he hoped the India sales to cross a billion dollar “relatively soon“. Cipla has stepped up launch plans in areas like respiratory, dermatology, cardiovascular and urology, which will help speed up its India growth. Also, several Indian and multinational drug makers have evinced interest in partnering with Cipla, said Vohra, who took over from Subhanu Saxena this month. He...

India's Supreme Court had directed drug maker Cipla to deposit a sum of Rs 175.07 crore within six weeks in a case related to alleged overcharging in certain drugs as per the provisions of Drug (Price Control) Order, 1995.   In a note to stock exchanges late on Friday, Cipla said the writ petitions filed in the Bombay High Court that were pending before Supreme Court have been retransferred to the Bombay High Court for final hearing. The initial order for the deposits was issued by Supreme Court in 2003, which had directed the government to recover 50% of the overcharged amount by the company.   "The Bombay High Court will now hear these matters on merits," the drug maker said. Cipla and India's drug pricing watchdog have been in a drawn-out legal tussle. The authority has charged Cipla of charging higher prices for a set of drugs than the ceiling price based on a fixed formula. Source: http://economictimes.indiatimes.com/industry/healthcare/biotech/pha...

Battling monopoly and batting for the indigenous industry, YK Hamied scripts the drug-maker’s journey as challenges loom “ The best is yet to come .” That was the message from Cipla doyen Yusuf K Hamied in his townhall address to employees across the world, to mark the company’s 80th anniversary. Cipla has entered a dynamic phase in its growth, he said, outlining “six pillars” for the future — plants, products, partnerships, plans, passion and people. And this growth would also see the next generation of the Hamied family, with Samina Vaziralli (his niece) taking a hand to preserving the essence of the company. For those following the company’s journey, Cipla’s “best” may have been in 2001, whenit rocked the pharma world by offering the HIV/AIDS three-in-one drug Triomune at less than a dollar a day, breaking the stranglehold of Big Pharma in South Africa. The combined international price of these drugs then was $12,000 per patient per year. In fact, some health advo...

Lupin Ltd. , India's second-largest drugmaker by market value, and Cipla Ltd. are among companies that bid for UCB SA's U.S. generic-drug business. The Indian companies submitted first-round offers for UCB's Kremers Urban Pharmaceuticals Inc. unit in late April. The business could be valued at about $1 billion. The Brussels-based drugmaker is selling Kremers Urban as it focuses on drugs for central nervous system illnesses and immunology. Indian drugmakers have been considering acquisitions to better compete with market leader Sun Pharmaceutical Industries Ltd after it acquired domestic rival Ranbaxy Laboratories Ltd. Dr. Reddy's Laboratories Ltd., based in Hyderabad, has already agreed to buy UCB's brands in India for 118 million euros ($129 million). Source:  http://timesofindia.indiatimes.com/business/international-business/Lupin-Cipla-Said-to-Bid-for-UCBs-1-billion-US-generics-unit/articleshow/47507952.cms