The Department of Justice announced that three pharmaceutical companies — Jazz Pharmaceuticals (JAZZ), Lundbeck (HLUYY), and Alexion Pharmaceuticals (ALXN) – have agreed to pay a total of $122.6M to resolve allegations that they each violated the False Claims Act by illegally paying the Medicare or Civilian Health and Medical Program copays for their own products, through purportedly independent foundations that the companies used as mere conduits. Jazz and Lundbeck each entered five-year corporate integrity agreements, or CIAs, with OIG as part of their respective settlements. The CIAs require the companies to implement measures, controls, and monitoring designed to promote independence from any patient assistance programs to which they donate. In addition, the companies agreed to implement risk assessment programs and to obtain compliance-related certifications from company executives and board members.
Thursday, April 4, 2019
FDA cancer chief urges China players to bring low cost PD-1 meds to US
Richard Pazdur, director of FDA’s Oncology Center of Excellence, is urging Chinese companies to bring PD-1/PD-L1 inhibitors to the U.S. market and undercut the prices charged by multinational pharmas.
Chinese companies competing in the U.S. on the price of PD-1s “could potentially be a great thing for everyone because we haven’t seen the major western pharmaceutical companies moving on price,” Pazdur said at the American Association for Cancer Research meeting. He spoke from the audience during the question and answer portion of a session titled “East meets West: Chinese pharma explores Western markets.”
FDA could approve a drug, including a PD-1/PD-L1 inhibitor, based solely on clinical data from China, Pazdur said. He reported that on a visit to China last summer, he was frequently asked if FDA would accept applications with clinical data generated only in China. “The answer is yes, if it is good quality.”
He said he was also asked if FDA considers price when making regulatory decisions. Pazdur said FDA does not consider price, but he also made it clear that the agency would welcome lower-cost PD-1/PD-L1 inhibitors.
He noted that six PD-1s have been approved in the U.S. and “there are no differences in price.”
FDA has approved six PD-1/PD-L1 inhibitors from seven companies for nearly 50 indications: Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), Tecentriq atezolizumab from Roche (SIX:ROG; OTCQX:RHHBY), Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE), Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Libtayo cemiplimab-rwlc from Regeneron Inc. (NASDAQ:REGN).
Multinational pharmas have created a playbook for PD-1s that could streamline the development of competing products, according Pazdur.
“I could see a very easy development strategy,” he said. “In lung cancer, for example, you could simply do the studies that the major pharmaceutical companies have already done. In fact, you already know the effect size to aim at, so these are very, very low-risk studies [that] could lead to full approval of these drugs.”
Warming on the theme, Pazdur told Chinese companies: “You don’t have to do a non-inferiority study. You already know the effect size. There’s very little risk here.” He added that the statistical plan would be so easy to write “you don’t even have to be a statistician to do it.”
He also suggested that FDA approval of Chinese PD-1s based on development programs that mimicked FDA-approved products would be smooth. “Obviously, they could have very similar results, so we would have very little to say in the approval of these drugs.”
Chinese manufacturers have already launched PD-1s in China at substantial discounts to competing products from multinational pharmaceutical companies.
For example, in January Shanghai Junshi Biosciences Co. Ltd. (HKSE:1877) priced its domestically developed anti-PD-1 mAb Tuoyi toripalimab at an 83% discount compared with the China price of Keytruda.
Another Chinese company, Innovent Biologics Inc. (HKSE:1801), set the price of its anti-PD-1 mAb Tyvyt sintilimab (IBI308) at a 56% discount compared with Keytruda’s price in China.
Innovent is co-developing Tyvyt in China with Eli Lilly and Co. (NYSE:LLY). The mAb was approved by China’s National Medical Products Administration in December for relapsed or refractory classical Hodgkin lymphoma (see “China’s NMPA Approves Innovent’s PD-1 mAb Tyvyt for Hodgkin Lymphoma”).
The AACR “East meets West” session was moderated by Joshua Berlin, executive director of new ventures at BioCentury. Speakers included Dan Zhang, executive chairman of Chinese CRO Fountain Medical Development Ltd. (Beijing, China), Frank Jiang, chairman and CEO of immuno-oncology company CStone Pharmaceuticals Co. Ltd. (HKSE:2616), and Joan Shen, head of R&D at I-Mab Biopharma (Shanghai, China).
On a separate AACR panel, Pazdur pressed representatives from Western companies with marketed PD-1/PD-L1 inhibitors to explain why they aren’t collaborating more in the clinic and whether their respective molecules were “clinically” different (see “Pazdur Grills PD-1/PD-L1 Companies Over Lack of Collaboration, Trial Redundancies”).
Departing FDA chief Scott Gottlieb heads to American Enterprise Institute
Dr. Scott Gottlieb, who resigned last month from the top post at the U.S. Food and Drug Administration, is heading back to the American Enterprise Institute to work on drug pricing.
The Washington Post first reported the story on Thursday. Gottlieb will leave the agency on Friday.
AEI’s Director of Economic Policy Studies Michael Strain confirmed it via Twitter where he wrote that he and his colleagues are “thrilled” that Gottlieb is “coming home” to the Washington think tank. Gottlieb first went to AEI as a resident fellow in 2003.
As commissioner, he sped up approvals of generic drugs and pushed for transparency measures. Both are noncontroversial approaches to high pharmaceutical costs, and so far this year Congress is following suit with similar measures for the expected legislative package.
AEI is well respected in policy circles and advises Congress on the administration on major policies. Experts of the think tank have been critical of one of the Trump administration’s boldest ideas to drive down drug prices: the proposed demonstration to set an international reference price model for Medicare Part B.
Last week AEI’s James Capretta published an op-ed in Real Clear Politics to counter the proposal.
” Drug companies see the U.S. as their most important market because it is critical to reaching their global revenue goals,” Capretta wrote. “A U.S.-based (international reference pricing) scheme is more likely to lead to delays in product launches elsewhere, and to more creative price evasion schemes, than to lower prices for U.S. consumers or taxpayers.”
AbbVie announces new formulary listings for MAVIRET
AbbVie announced that MAVIRET is now reimbursed in Alberta, Saskatchewan and the Non-Insured Health Benefits Program. MAVIRET is a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus infection across all major genotypes. In Alberta, MAVIRET is listed effective April 1, 2019, under Special Authorization on the AB Health Drug Benefit List for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria. Prescribed by or in consultation with a hepatologist, gastroenterologist or infectious disease specialist; AND Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6; AND Laboratory confirmed quantitative HCV RNA value within the last 6 months; AND Fibrosis stage of F0 or greater. In Saskatchewan, MAVIRET is listed effective April 1, 2019, on the Saskatchewan formulary as an Exception Drug Status product, for treatment naive and treatment experienced adult patients with chronic hepatitis C infection according to the following criteria: Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5 or 6; AND Laboratory confirmed quantitative HCV RNA value within the last six months; AND Treatment is prescribed by a hepatologist, gastroenterologist or an infectious disease specialist or other prescriber experienced in the treatment of hepatitis C as determined by the Drug Plan. For the Non-Insured Health Benefits program, MAVIRET is listed effective April 1, 2019, under Limited Use on the NIHB Drug Benefit List for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: Prescribed by or in consultation with a hepatologist, gastroenterologist or infectious disease specialist; AND Laboratory confirmed hepatitis C genotype 1, 2, 3, 5, 6; AND Laboratory confirmed quantitative HCV RNA value within the last 6 months; AND Fibrosis stage of F0 or greater.
Tonix to Expand Phase 3 Program Beyond PTSD to Include Fibromyalgia
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced today the expansion of the TNX-102 SL 5.6 mg program beyond posttraumatic stress disorder (PTSD) to include Phase 3 development for TNX-102 SL* in fibromyalgia. TNX-102 SL or Tonmya®** is Tonix’s lead Phase 3 program in PTSD with the Phase 3 RECOVERY trial actively enrolling military and civilian PTSD participants.
In a recent Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA), Tonix received clear guidance and support to advance the development of TNX-102 SL, a non-opioid centrally-acting analgesic, for the management of fibromyalgia. Acceptable study design features were discussed to establish the safety and efficacy of TNX-102 SL 5.6 mg in a pivotal study to support the fibromyalgia indication.
A lower dose of TNX-102 SL (2.8 mg) taken daily at bedtime was studied previously in fibromyalgia in a Phase 2 study and a Phase 3 study. Both studies showed clinical benefits especially in the quality of sleep improvement, however, primary analyses on pain reduction were not statistically significant. Additional data developed by Tonix in the PTSD program showed that TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) demonstrated acceptable tolerability with additional clinical benefit in pain reduction for trial participants with PTSD. There were no serious and/or unexpected adverse events reported; the most common adverse events were mostly related to local administration site reactions, such as oral hypoaesthesia and abnormal product taste.
Shineco in Pact with China Region Government on Industrial Hemp Planting
Shineco, Inc. (“Shineco” or the “Company”;NASDAQ: TYHT), a producer and distributor of Chinese herbal medicines, organic agricultural produce, specialized textiles, and various health and well-being focused plant-based products in China, announced today that the Company, through its wholly owned subsidiary Tenjove NewHemp Biotech Co., Ltd. (“TNB”), entered into a strategic cooperation agreement (the “Agreement”) with the Xingshan People’s Government of Hegang City of Heilongjiang Province (the “Government”).
Pursuant to the Agreement, both parties agree to actively promote the development of a complete industrial chain for industrial hemp including cultivation, harvesting, initial processing and fine extraction to form a local industry integration model and to achieve a new industrial scale economy.
As part of the Agreement, both parties plan to develop a 20,000 mu (approximately 3,295 acres) high-quality industrial hemp project and expect to complete the cultivation of the first 500 mu in 2019. Besides conducting joint research and development on several new varieties of industrial hemp, both parties also agree to establish an industrial hemp farm, a CBD Extraction Industrial Park, an Industrial Hemp Research Center affiliated with the China’s Academy of Science, and an Industrial Hemp Workstation sponsored by the City of Hegang of Heilongjiang Province.
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