This week, Phispers (Pharmaceutical Whispers) covers news about Novartis paying US $ 25 million to settle an SEC case, Gilead to pay US $ 200 million to Merck for patent infringement of Hepatitis C drugs, Sun Pharma’s entry into Japan, data-integrity issues at Cadila’s vaccine plant in Gujarat and how 2016 is poised to be a big year for generics.
While Novartis’ settles cases in China & U.S., a bribery scandal emerges in Turkey
While Novartis was contending with a bribery probe in South Korea, its practices came up for questioning in America, Turkey and China.
Novartis paid US $ 25 million to settle a US Securities and Exchange Commission (SEC) case that claimed the Swiss drug maker paid bribes to health professionals in China to increase sales during 2009 and 2013.
Novartis’ nearly 80,000 “sham” events used to encourage doctors to prescribe several blood pressure medicines are being questioned by the US Department of Justice, which has documents that allege the same. The SEC issued a cease-and-desist order last week saying Novartis submitted a settlement offer and SEC has accepted it. The company’s payment includes US $ 2 million in civil penalty and US $ 1.47 million in interest. The trial is an outgrowth of a whistleblower lawsuit filed five years ago by Oswald Bilotta, a former Novartis sales representative.
While the U.S. case was settled, Novartis has been accused by a whistleblower in Turkey of “paying bribes in Turkey through a consulting firm to secure business advantages worth an estimated $85 million.”
Gilead to pay Merck US $ 200 million for patent infringement
Last week, a federal jury in the US ordered Gilead Sciences to pay Merck & Co US $ 200 million in damages for infringing two Merck patents related to a lucrative cure for hepatitis C.
Merck had demanded US $ 2 billion, so the damages awarded is only a tenth of the demand. Two days before this judgement, the same jury in San Jose, California, had upheld the validity of the patents, which lie at the heart of the dispute over Gilead's blockbuster drugs – Sovaldi and Harvoni.
Together, the medicines had more than US $ 20 billion in US sales in 2014 and 2015. Merck is trying to catch up with Gilead, which dominates the market on a new generation of hepatitis C drugs that can cure over 90 percent of patients with the liver disease.
World’s first 3D printed drug hits the market
Last year, PharmaCompass had reported that Aprecia Pharmaceuticals has got the approval for SPRITAM® (levetiracetam). And last week, the drug was officially launched in the market. SPRITAM is the first prescription drug product approved by the US FDA that is manufactured using 3D printing technology.
Aprecia announced that SPRITAM® tablets, for oral suspension, are now available as an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures. The product disintegrates in the mouth with a sip of liquid and offers a new option for patients, including those who may struggle to take their medicine.
The launch of SPRITAM should encourage other players to pursue drug development with renewed vigor.
Sun Pharma enters Japan by acquiring 14 brands from Novartis
Sun Pharmaceutical Industries has acquired 14 established prescription brands from Novartis AG and Novartis Pharma AG in Japan for US $ 293 million. These brands have combined annualised revenues of around US $ 160 million and address several medical conditions.
As per the agreement, Novartis will continue to distribute these brands for a certain period, pending transfer of all marketing authorization to Sun Pharma’s subsidiary. The brands will be marketed and distributed by a local partner under the Sun Pharma label.
“Japan is a market of strategic interest for us,” Dilip Shanghvi, managing director, Sun Pharma said. “This acquisition marks Sun Pharma’s foray into the Japanese prescription market and provides us an opportunity to build a larger product portfolio in the future,” he added.
India shoots down claim that compulsory licenses are a thing of the past
India's Commerce Ministry has shot down claims by the US-India Business Council that compulsory licenses for drugs are a thing of the past.
A Press Trust of India report termed news regarding the government’s rumored private assurances to the lobby group stating it will not issue any more compulsory licenses as incorrect. “It is hereby clarified that such reports are factually incorrect. In this regard, it may be noted that India has a well-established TRIPS (Trade Related aspects of Intellectual Property Rights) compliant legislative, administrative and judicial framework to safeguard IPRs," the ministry said in a statement.
This news comes at a time when Romania has been considering compulsory licensing in order to bring down the prices of life-saving drugs.
After FDA troubles, WHO uncovers data-integrity issues at ZydusCadila’s vaccine facility
Cadila Healthcare has received a Notice of Concern (NoC) from the World Health Organization (WHO) for violation of good manufacturing practices at its vaccine plant in Moraiya, Gujarat. The NoC is based on an inspection held in October last year.
Deficiencies include those in the area of data integrity. The notice was posted last week on the WHO website. The plant manufactures Lyssavac-N, an anti-rabies vaccine and is located in the vicinity of the formulation facility that received an FDA warning letter on December 31 over non-compliance with manufacturing standards.
Cadila said it has responded to WHO and has been implementing remedial measures.
Last week, there was news that the Central Drugs Standard Control Organization (CDSCO) will soon start surprise checks at manufacturing sites. The move, along the lines of FDA inspections, is part of an exercise to ensure the local market isn't flooded with substandard medicines.
Will we see a reduction in such notices, now that the Indian government has announced surprise inspections of facilities to curb compliance shortcomings?
2016 a big-year for first time generics
2016 is expected to be a big year for first-time generics, with an estimated US $ 20 billion targeted for going generic.
With several name brand drugs falling off patent, new biosimilars potentially gaining approval, and new treatments for cancer, diabetes and hepatitis C, 2016 is shaping up to be a blockbuster year for drugs to gain approval from the FDA.
In February, Sun Pharmaceuticals launched a generic to Novartis’ Gleevec® (imatinib mesylate), a drug first approved in 2001 for treating Philadelphia chromosome positive (Ph+) chronic myeloid leukemia.
Several breakthrough cancer therapies may reach the market in 2016, following the trends of recent years. Under FDA guidelines established in July 2012, drugs designated as breakthrough therapies undergo an expedited development and review process.
Biocon receives regulatory nod for insulin glargine in Japan
The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Biocon’s biosimilar insulin glargine. The product is a ready-to-use, prefilled disposable pen with insulin glargine and is expected to be launch in the coming three months.
Japan is the second largest market outside of North America and Europe and is largely dominated by disposable pens. Biocon’s insulin glargine is expected to capture a significant share of the Japanese glargine market of US $ 144 million.
The approval was granted after successful completion of initial development by Biocon and local phase III clinical studies in over 250 type 1 diabetes patients by Biocon’s partner in Japan.
Roche opens the door for external partnerships in the battle against cancer
Switzerland-based Roche Holding AG, the world’s largest producer of cancer drugs, is opening its door for more external partnerships with its latest and most promising tumor-fighting treatment heading for approval this year.
Last week, Roche formed partnerships with Kite Pharma and Johnson & Johnson to explore combinations using its experimental drug – atezolizumab. The Roche medicine will be studied with Kite’s experimental custom-cell therapy and with Johnson & Johnson’s Darzalex, which is approved in the US for use on multiple myeloma patients.
Atezolizumab belongs to a group of cancer treatments known as immunotherapies, which harness the power of the body’s immune system to kill cancer cells. Roche is trying to carve out a share of the market for these new treatments, which analysts estimate may reach US $ 24 billion by 2020.
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : wanderer_5_by_ziggysart2-d5o6xq3 by z s is licensed under CC BY 2.0 // Modification: the PharmaCompass logo was added to the original image.
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
