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BioCentury Extra
As published Wednesday, August 24, 2016 5:51 PM PST


  • Biotechs slide after Clinton's EpiPen comments

    In a statement responding to price increases for EpiPen from Mylan N.V. (NASDAQ:MYL), Hillary Clinton slammed drug companies that "put profits ahead of patients, raising prices without justifying the value behind them." Shortly after the posting, biotech indices slid Wednesday.

    Clinton reiterated her commitment to address "exorbitant" drug price hikes, and vowed if elected to force drug companies to "explain significant price increases, and prove that any additional costs are linked to additional patient benefits and better value." Her statement linked to a September 2015 position paper on lowering prescription drug prices that includes a plan to require drugmakers that benefit from federal support to invest "a sufficient amount of their revenue in R&D, and if they do not meet targets, boost their investment or pay rebates to support basic research."

    The paper also says that if elected, Clinton will "build on provisions in the Affordable Care Act that invest in private research, and other private efforts, to use the results of private-sector analyses to hold drug companies accountable for justifying their costs and ensure Americans pay drug prices that reflect the improved value new treatments provide."

    Over the past few days, a handful of U.S. Senators have criticized Mylan's price increases for the epinephrine auto-injector, which is marketed to treat severe acute allergic reactions. On Wednesday, a bipartisan group of Senators asked FDA to discuss its approval process for potential competitors to EpiPen that could lower its cost (see BioCentury Extra, Aug. 23).

    The BioCentury 100 Index slipped 193.23 (3.6%) to 5242.72 on Wednesday, with decliners outnumbering gainers 93-7. The NASDAQ Biotechnology Index (NBI), iShares NASDAQ Biotechnology ETF (IBB) and the NYSE Arca Biotechnology Index (BTK) each fell 3.4%.

    Clinton's proposal to lower prescription drug costs includes a cap on out-of-pocket prescription costs and increased rebates for Medicare Part D drugs to Medicaid-mandated levels (see BioCentury Extra, Sept. 22, 2015).

    Mylan lost $2.49 to $43.13 on Wednesday, and has slipped 11% since its Aug. 19 close of $48.66, before public criticism mounted.

  • Pfizer buying AZ's small molecule anti-infectives business

    Pfizer Inc. (NYSE:PFE) is acquiring the small molecule anti-infectives business of AstraZeneca plc (LSE:AZN; NYSE:AZN) for $550 million in cash up front and $175 million due in January 2019. The unit includes approved drugs Zavicefta ceftazidime/avibactam, Zinforo ceftaroline fosamil and Merrem/Meronem meropenam, as well as a pair of Phase II candidates.

    AstraZeneca is eligible for $250 million in milestones and $600 million in "sales-related payments," plus tiered royalties on sales of Zavicefta and pipeline candidate ATM-AVI.

    The European Commission approved Zavicefta in June to treat complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP) and aerobic Gram-negative infections. The therapy is a fixed-dose combination of ceftazidime, a third-generation cephalosporin; and avibactam, a broad-spectrum beta lactamase (LACTB) inhibitor. Allergan plc (NYSE:AGN) has commercialization rights in North America; it is known as Avycaz in the U.S.

    Pfizer said combined sales of established antibiotics Zinforo and Merrem were $250 million in 2015. Zinforo is approved to treat complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP). Allergan holds Zinforo's rights in North America, and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) has rights in Japan. Merrem is approved to treat a range of bacterial infections. Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) holds rights to Merrem in certain Asian territories.

    The deal also gives Pfizer rights to ATM-AVI and CXL, both of which are in Phase II testing. ATM-AVI combines antibiotics aztreonam and avibactam, and is in development to treat Gram-negative infections. CXL, which combines Zinforo and avibactam, is being studied for methicillin-resistant Staphylococcus aureus (MRSA) infections. Allergan has North American rights to both candidates.

    AstraZeneca has been divesting non-core assets to generate funding for internal R&D. Last year, it spun out its early stage anti-infectives unit into Entasis Therapeutics Inc. (Waltham, Mass.) (see BioCentury, April 18).

    The deal is Pfizer's second substantial acquisition this week. The pharma said Monday it would acquire oncology company Medivation Inc. (NASDAQ:MDVN) for about $14 billion (see BioCentury Extra, Aug. 22).

    Pfizer and AstraZeneca expect their deal to close next quarter.

  • FDA rejects Amgen's Parsabiv

    Amgen Inc. (NASDAQ:AMGN) received an FDA complete response letter for Parsabiv etelcalcetide to treat secondary hyperparathyroidism in hemodialysis-dependent adults with chronic kidney disease.

    Spokesperson Kristen Davis declined to disclose FDA's concerns with the NDA for Parsabiv, a peptide calcimimetic that acts on the parathyroid gland to reduce production of parathyroid hormone (PTH). The company said it hopes to meet with FDA this year to discuss the letter.

    The IV therapy met the primary endpoints in three Phase III studies, including two placebo-controlled trials and a head-to-head trial vs. Sensipar/Mimpara cinacalcet, an oral second-generation calcimimetic that Amgen markets in the U.S. and EU. Davis said patent coverage extends into March 2018 for Sensipar, which is approved in the U.S. to treat secondary hyperparathyroidism and hypercalcemia.

    Amgen lost $3.56 to $170.84 on Wednesday. It announced the news after market hours.

  • PTAB invalidates two of Teva's Copaxone patents

    In an inter partes review (IPR) proceeding, the U.S. Patent Trial and Appeal Board invalidated all 20 claims in each of two patents covering a thrice-weekly formulation of multiple sclerosis treatment Copaxone glatiramer acetate from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA). PTAB instituted a review of the patents last year following an IPR challenge from Mylan N.V. (NASDAQ:MYL) (see BioCentury Extra, Aug. 26, 2015).

    Teva has five Orange Book-listed patents protecting thrice-weekly Copaxone. Both invalidated patents -- U.S. Patents Nos. 8,232,250 and 8,399,413 -- expire in 2030. PTAB struck down both patents based on the same prior art, saying that a person of ordinary skill would have been able to modify Copaxone's dosing schedule to the thrice-weekly dosage protected by the patents.

    Both patents are owned by Yeda Research and Development Co. Ltd. and are licensed to Teva.

    In a statement, Teva said it plans to appeal Wednesday's PTAB decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). The company said it is "prepared to defend the full suite of our intellectual property through the PTAB and U.S. courts regardless of the time required." It said it will defend all five Orange Book-listed patents against filers of multiple ANDAs in a trial scheduled to begin next month in the U.S. District Court for the District of Delaware.

    In June 2015, CAFC invalidated the last U.S. patent for once-daily Copaxone, allowing the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) to launch its generic version, Glatopa (see BioCentury Extra, June 18, 2015).

  • NICE backs Eylea for visual impairment due to BRVO

    The U.K.'s NICE issued a final appraisal determination recommending the use of Eylea aflibercept from Bayer AG (Xetra:BAYN) to treat visual impairment in adults caused by macular edema after branch retinal vein occlusion. The recommendation is contingent on Bayer providing the drug at an undisclosed discount under a patient access scheme.

    In draft guidance released in June, NICE recommended Eylea for the indication only in patients for whom laser photocoagulation had not been beneficial or was not suitable because of the extent of the hemorrhage.

    In the FAD, the committee said it concluded that Eylea is "more clinically effective" than laser photocoagulation, and that clinical experience suggests the drug is more effective when given before photocoagulation, rather than after.

    NICE already recommends Eylea for other ophthalmic indications, including diabetic macular edema (DME).

    Bayer has ex-U.S. rights to Eylea from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN). It is a human fusion protein that binds all forms of VEGF-A and placental growth factor (PGF; PIGF).

  • Lee's, Shenogen to develop cancer combo therapy

    Lee's Pharmaceutical Holdings Ltd. (HKSE:0950) and Shenogen Pharma Group Ltd. (Beijing, China) plan to develop a combination therapy in China to treat late-stage cancers. The partners intend to investigate Pexa-Vec pexastimogene devacirepvec (JX-594, TG6006), an oncolytic virus candidate from Lee's, in combination with Shenogen's icaritin (SNG-162).

    The partners expect synergistic effects from the combo based on animal studies. Financial terms of their deal were not disclosed. Neither company responded to inquiries.

    The partners said a Phase II trial of icaritin to treat hepatocellular carcinoma (HCC) was recently completed in China. SillaJen Inc. (Busan, South Korea) is conducting an international Phase III trial of Pexa-Vec in the same indication. Lee's has rights to Pexa-Vec in Greater China from SillaJen.

    Icaritin is a small molecule derived from a Chinese herb targeting estrogen receptor alpha 36. Pexa-Vec is a recombinant vaccinia virus engineered with the addition of GM-CSF and deletion of thymidine kinase.

  • Management tracks

    Cancer company BeiGene Ltd. (NASDAQ:BGNE) named Amy Peterson CMO of immuno-oncology, replacing interim CMO Eric Hedrick. Peterson was VP of clinical development at Medivation Inc. (NASDAQ:MDVN), which Pfizer Inc. (NYSE:PFE) is acquiring. Hedrick will continue to oversee BeiGene's hematology programs and serve as an advisor to the company.

    Mitochondrial medicine company NeuroVive Pharmaceutical AB (SSE:NVP; Pink:NEVPF) said COO Jan Nilsson is leaving the company. NeuroVive said the position is no longer needed following a reorganization.

    Respiratory company Spyryx Biosciences Inc. (Durham, N.C.) named Alistair Wheeler CMO. He was global head of clinical development, respiratory medicine and biotherapeutics at the Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506).

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) named Paul Herendeen CFO and EVP of finance, replacing Robert Rosiello. Herendeen was EVP and CFO at Zoetis Inc. (NYSE:ZTS). Rosiello will become Valeant's EVP of corporate development and strategy.

    CNS company Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) named Todd Young EVP and CFO. He was SVP and treasurer at Baxalta Inc., which Shire plc (LSE:SHP; NASDAQ:SHPG) acquired.

  • BIO releases principles on interacting with patient groups

    In a set of principles concerning how its member companies engage with patient advocacy organizations, BIO said its members should "value and embrace the autonomy" of patient groups, which may develop different public policy and scientific agendas than industry does.

    Companies "should not attempt to compel" patient advocacy stakeholders to adopt specific policy positions, but when companies and patient groups share policy objectives, they should "work together as equal partners," the principles said.

    When companies fund patient groups for patient support services, the principles said the "objective, scope, and deliverables of any collaboration should be transparent and ethical," and the funds should not be intended to influence a group's public policy positions. BIO and its member companies also "should not expect promotion or endorsement of a specific product" when partnering with or funding patient advocacy groups.

    The principles also said BIO and its members respect the privacy of data from patient advocates, and do not expect the groups to share personal information.

    BIO has released several other sets of voluntary principles this year, including a set of commitments to support ways of improving patients' ability to afford and gain access to innovative medicines (see BioCentury Extra, Feb. 3).


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