This
week, Phispers brings you the latest twist in the Singh brothers-Daiichi 2008
Ranbaxy sell-off saga. There is also news on the benefits of new diabetes and
cholesterol drugs to the heart; amendments to drug regulations in Canada; a
class action suit against Sun and Mylan in the US; and the sale of the
controversial DMD drug by Marathon. Read on.
Singhs fight back; say Daiichi’s profits outweigh losses incurred in buying Ranbaxy
Last year, a Singapore tribunal had ordered the former promoters of Ranbaxy — Malvinder and Shivinder Singh — to pay Daiichi Sankyo US $ 391 million (Rs 25.62 billion) in damages for concealing information regarding wrongdoings at Ranbaxy. The Singh brothers had sold their majority stake in Ranbaxy to the Japanese drug maker in 2008 for US$ 4.6 billion.
Last week, the Singh brothers hit back at Daiichi. The Singh brothers now claim Daiichi has made profits that far outweigh the losses it incurred in buying Ranbaxy in 2008.
According to a new application filed in the Delhi High Court, the Singhs claim Daiichi had availed monetary benefits of around US$ 1.2 billion (Rs 80 billion) during the time it bought and sold Ranbaxy. This amount is more than twice the damages Daiichi is seeking through its arbitration enforcement case against the brothers.
The application further states that such monetary benefits should have been factored in by the Singapore tribunal in assessing the damages.
According to this new application, Daiichi made further profits from the sale of its shares in Ranbaxy to Sun Pharma in 2015.
Singhs have appealed in both the Delhi High Court as well as in Singapore. The brothers claim “substantive objections” exist under India’s arbitration law to make the order unenforceable.
Data-integrity
violations uncovered at USV in India; more violations at Jinan Jinda in China
USV Private Limited: Another major Indian pharmaceutical company — 55 year-old USV Private Limited — received an FDA warning letter after shortcomings were uncovered at its finished pharmaceuticals manufacturing facility in Dabhel (in Daman) during a June 2016 inspection.
While the FDA questioned the practices at USV’s microbiological laboratory and its way of conducting smoke studies, data integrity violations were yet again cited in the warning letter.
According to the warning letter, at USV “all users could delete or modify files” and investigators uncovered six deleted tests on two different equipment. In another instance, where a sample had “failed identity testing”, USV accepted a passing retest result “without any investigation of the failed result”.
The warning letter goes on to mention that the “FDA cited similar CGMP violations at other facilities in USV’s network.”
In the financial year 2015-16, USV’s total income was US$ 388 million (Rs 25.4 billion). USV’s Indian business contributed 82 percent to the revenue and the rest was from export of APIs and finished dosages.
Jinan Jinda Pharmaceutical: The US FDA had placed Jinan Jinda Pharmaceutical Chemistry Company Ltd on its Import Alert list in November 2015. An inspection conducted six months earlier, by the Italian Ministry of Health, had uncovered an unofficial and non-controlled storage area that contained mainly raw materials and finished products, and was made inaccessible to the inspectors. Since the door of the area had been removed and replaced with a panel fixed with screws to the wall, the inspection team concluded that there was a serious risk of data falsification.
A June 2016 inspection by the FDA uncovered that when an out of specification (OOS) unknown impurity peak was found during high performance liquid chromatography (HPLC) testing, the chemists terminated the analysis. When repeat testing also showed the OOS impurity peak, the chromatogram was manually edited to hide the presence of the peak. In another case, where seven sample injections were required to test for impurities, the analysts permanently deleted the first five sample injections and then renamed the last two injections and reported that they met specifications.
With repeated concerns of data-integrity, FDA’s warning letter clearly spells out what is expected from the firm going forward. This includes — “a comprehensive investigation into the extent of the inaccuracies in data records and reporting”; and “a current risk assessment of the potential effects of the observed failures on the quality” of drugs manufactured by Jinan Jinda.
The letter states that Jinan Jinda’s assessment should include “analyses of the risks to patients”. It goes on to add that the company’s management strategy should include the details of the company’s “global corrective action and preventive action plan.”
Drug
makers in Canada to publicly disclose drug shortages
Last week, amendments to Canada’s Food and Drug Regulations came into force, making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations. These will now have to be reported to two websites — DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca.
The public-facing website of Canada — www.drugshortages.ca — said: “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a shortage on the communications platform.”
According to Health Canada, the posting of discontinuances on the shortages website “does not alter nor affect regulatory obligations under the Food and Drug Act Regulations to inform Health Canada within 30 days of any drug discontinuances.”
Sun,
Mylan face class action suit in US over price fixing of asthma drug
A class action suit was filed in the Pennsylvania federal court last week by the New York grocery workers’ union against Sun Pharmaceutical Industries and Mylan. The lawsuit alleged that the two companies conspired to raise the price of a generic asthma medicine — Albuterol, or albuterol sulfate tablets.
Albuterol is a bronchodilator, used by patients suffering from wheezing.
The suit — filed by the United Food and Commercial Workers local unit — stated that Sun and Mylan had raised their prices for albuterol sulfate over 3,000 per cent between October 2013 and April 2014.
“Beginning in May 2013, defendants caused the price of albuterol sulfate to dramatically increase in unison. The increases were the result of an agreement among them to increase pricing and restrain competition for the sale of albuterol sulfate in the US,” the complaint alleged.
The New York union also filed another suit for similar charges against Mylan and Sandoz for colluding to raise the cost of another generic asthma medicine — Benazepril HCTZ.
New
age diabetes and cholesterol drugs will also protect your heart
There are new drugs that significantly protect your heart, and reduce the risk of death and hospitalization. Take the case of a newer class of type 2 diabetes drugs — known as SGLT-2 inhibitors — that significantly reduce the risk of death and hospitalization for heart failure as compared to other medicines for diabetes. This was brought out by a study sponsored by AstraZeneca.
SGLT-2 inhibitors work by removing blood sugar via the urine. They are sold under various brand names such as AstraZeneca’s Farxiga, Eli Lilly and Boehringer Ingelheim’s Jardiance and Johnson & Johnson’s Invokana.
Similar breakthrough was reached by Amgen through its cardio research that highlighted health benefits of its PCSK9 cholesterol drug — Repatha. This drug was studied by Amgen for two years, across 27,564 patients. “Repatha was able to lower a composite of cardio risks by an average of 20 percent. And the improvement increased with time, growing from a 16 percent risk advantage in year one to 25 percent after 12 months,” a news report said.
In 2015, a clinical trial conducted on Eli Lilly and Boehringer Ingelheim’s Jardiance to reassure it does not cause heart problems instead showed it reduced the combined risk of hospitalization for heart failure or death from heart failure by 39 percent in high risk patients. Since then, this heart benefit has been incorporated in Jardiance’s label.
Meanwhile, AstraZeneca is conducting its own large clinical trials to determine the heart effect of Farxiga. The results of these trials are expected in 2019.
After
pricing outrage, Marathon sells DMD drug to PTC Therapeutics
After weeks of public and political outrage over the pricing of its Duchenne muscular dystrophy (DMD) drug — Emflaza — Illinois-based Marathon Pharmaceuticals said it will sell the drug to PTC Therapeutics.
PTC Therapeutics will pay US $140 million in cash and stock for Emflaza. Marathon will also receive payments from the New Jersey-based PTC on sales of the drug, starting in 2018. DMD is a rare genetic disorder that causes progressive muscle deterioration and weakness.
On February 9 this year, Marathon received FDA approval for Emflaza (deflazacort), tablets and oral suspension, to treat patients of DMD, aged five years and older.
Subsequently, Marathon announced it would charge a list price of US $ 89,000 a year in the United States for Emflaza. Outside the US, the drug is available for US $ 1,000 a year.
This led to public outrage, and even the FDA — which had approved Emflaza only in February this year — questioned the drug’s approval. This was the first FDA approval of any corticosteroid to treat DMD and the first approval of deflazacort for any use in the US.
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