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BioCentury Extra
As published Tuesday, September 16, 2014 7:04 PM PST


  • Takeda announces global reorganization

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) announced the reorganization of its commercial and R&D operations -- its first major organizational move since naming Christophe Weber as COO effective April 2014 and president effective June 2014.

    Takeda said the reorganization is designed to strengthen communication between its commercial and R&D divisions.

    Takeda's commercial division will establish five regional business units, as well as two specialty business units for oncology and vaccines, by April 1, 2015. The five commercial units will be Japan Pharma, U.S., Europe-Canada, Emerging Markets and Japan Consumer Healthcare. Christophe Bianchi, EVP of Takeda's oncology-focused Millennium Pharmaceuticals Inc. subsidiary, will become president of the specialty oncology unit.

    Takeda will create the Japan Pharma unit by adding resources to its existing Pharmaceutical Marketing Division in Japan. It will merge its existing North Asia and Emerging Markets organizations to form an Emerging Markets unit based in Singapore.

    Takeda's R&D operations will be condensed from six therapeutic area units into four: CNS; cardiovascular and metabolic; gastroenterology; and oncology. Its existing R&D operations are divided into six therapeutic areas: CNS, cardiovascular and metabolic, oncology, immunology and respiratory, general medicine, and vaccines. Immunology research will be integrated into the CNS unit and respiratory research will fall under the CVM unit. The company said it will not terminate any pipeline programs due to the restructuring.

    Anna Protopapas, president of Millennium and head of global licensing and business development, will step down effective Oct. 1.

    Takeda said other positions in the company may be affected, but it has not determined its exact plans yet and intends to provide an update when it discusses first-half results on Oct. 31.

    Takeda had net sales of Y1.7 trillion ($16.4 billion), with an operating profit of Y139 billion, in the fiscal year ended March 31.

  • Lilly buys into AZ's BACE for Alzheimer's

    Eli Lilly and Co. (NYSE:LLY) will pay up to $500 million to AstraZeneca plc (LSE:AZN; NYSE:AZN) under a deal for the pharmas to jointly develop and commercialize AZ's AZD3293 for Alzheimer's disease.

    The partners said Phase I studies have shown that the oral beta-site APP-cleaving enzyme (BACE) inhibitor reduced the amyloid beta in cerebrospinal fluid of healthy volunteers and AD patients. The partners said they plan to "rapidly" move AZD3293 to a Phase II/III trial in patients with early AD, but did not disclose a timeline.

    Lilly said the compound is designed to inhibit BACE1, but is non-selective and equally inhibits BACE2.

    The partners will equally share development and commercialization costs and worldwide net revenues. AstraZeneca will manufacture the compound while Lilly will lead clinical development. The partners will be jointly responsible for commercialization.

    The $500 million in undisclosed milestones includes a $50 million payment in 1H15, which Lilly said it would recognize as a charge to earnings of about $0.03 per share in 3Q14.

    Lilly last year discontinued a Phase II AD trial on its own BACE1 inhibitor, LY2886721, after seeing abnormal liver biochemical tests.

    Merck & Co. Inc. (NYSE:MRK) already has its MK-8931 (SCH 900931) oral BACE1 inhibitor in two Phase III trials to treat AD. Final data are expected in April 2017 and March 2018.

    Boehringer Ingelheim GmbH (Ingelheim, Germany) is in Phase I trials with a BACE1 inhibitor in-licensed from IPO queue member Vitae Pharmaceuticals Inc. (Fort Washington, Pa.). Data are expected in 2H14.

  • Regeneron's Eylea gets breakthrough designation

    FDA granted breakthrough therapy designation to Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat diabetic retinopathy in patients with diabetic macular edema (DME). Regeneron plans to submit an sBLA for the vascular endothelial growth factor A (VEGF-A) inhibitor in the indication by year end.

    Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. To support the designation, preliminary clinical evidence must show the compound offers substantial improvement over therapies approved for the indication or over placebo on clinically significant endpoints when approved therapies do not exist.

    No drugs are approved for diabetic retinopathy.

    The breakthrough designation was based on data from two Phase III trials of Eylea for DME, an indication for which the drug is approved. Patients with diabetic retinopathy who were treated with Eylea in the VIVID-DME and VISTA-DME trials demonstrated significant improvements in diabetic retinopathy severity scale (DRSS) scores compared to patients in the laser-treated control groups.

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) submitted in August an sBLA for Lucentis ranibizumab, a humanized mAb fragment targeting VEGF-A, for diabetic retinopathy in patients with DME. Genentech did not comment on whether it sought breakthrough therapy designation for Lucentis (see BioCentury Extra, August 8).

    Eylea is under FDA review to treat macular edema following branch retinal vein occlusion (BRVO). The PDUFA date is Oct. 23.

    Regeneron closed up $9.44 to $355.47 on Tuesday.

  • FDA approves AZ's Movantik for OIC

    FDA approved an NDA for once-daily Movantik naloxegol from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain. AZ plans to launch the pegylated form of the peripheral mu opioid receptor (OPRM1; MOR) antagonist naloxol in 1H15.

    The approval of the once daily oral drug triggers a $35 million milestone payment to development partner Nektar Therapeutics (NASDAQ:NKTR). Movantik was developed using Nektar's oral small molecule polymer conjugate technology.

    Nektar also is eligible for a $100 million milestone payment upon U.S. launch, a $40 million payment upon EU launch, sales milestones totaling $375 million and royalties. Nektar expects a European decision on the OIC indication by year end.

    Movantik is a schedule II controlled substance based on its structural similarity to noroxymorphone. AZ has submitted a petition to the U.S. Drug Enforcement Agency (DEA) to de-schedule the drug. Also, the pharma plans to run a postmarket, observational epidemiologic cardiovascular safety study of Movantik. Nektar closed up $0.06 to $13.59 on Tuesday.

  • Endo bids $2.2B for Auxilium

    Endo International plc (NASDAQ:ENDP; TSX:ENL) made an unsolicited bid to acquire fellow specialty pharma Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) for $28.10 per share in cash and stock, or about $2.2 billion. The price is a 31% premium to Auxilium's Tuesday close of $21.52. Auxilium could not be reached for comment.

    Endo said Auxilium's 12 approved products would complement Endo's portfolio of drugs for pain and men's health. Auxilium reported 1H14 net revenues of $171.5 million. Citi is advising Endo.

    In June, Auxilium announced plans to merge with ophthalmic play QLT Inc. (TSX:QLT; NASDAQ:QLTI). On a conference call, Endo noted that its offer is only for Auxilium.

    Endo, which announced the bid postmarket, was up $0.56 to $65.17 on Tuesday. QLT was off $0.11 to $6.20 on NASDAQ and fell $0.95 (15%) to $5.25 in early after-hours trading. Auxilium jumped $8 (37%) to $29.52 in early after-hours trading on Tuesday.

  • Merck Serono, Lupin in emerging markets deal

    The Merck Serono S.A. biopharmaceutical division of Merck KGaA (Xetra:MRK) partnered with Lupin Ltd. (NSE:LUPIN; BSE:500257) to develop and commercialize up to 20 general medicines in emerging markets. Lupin will develop and supply products to Merck Serono, which will hold marketing authorizations and commercialize the products.

    Merck Serono said the deal will focus primarily on cardiovascular diseases and diabetes. The deal covers Latin America, Asia, central Eastern Europe and Africa, including major markets such as Brazil, Mexico, Indonesia and the Philippines, as well as undisclosed countries in Africa and central Eastern Europe.

    In Africa, additional therapeutic areas such as antibiotics will be included to reflect local healthcare needs. Merck Serono expects to launch the first products in 2016.

    Merck Serono recorded EUR 1.8 billion ($2.3 billion) in 2013 sales in emerging markets.

  • Jenkins joins Dimension as CEO

    Dimension Therapeutics (Cambridge, Mass.) hired Annalisa Jenkins as CEO. She previously was EVP and head of global R&D at the Merck Serono S.A. biopharmaceutical division of Merck KGaA (Xetra:MRK). Jenkins succeeds Dimension co-founder and interim CEO Thomas Beck, who is an executive partner at Dimension investor Fidelity BioSciences.

    Dimension is developing gene therapies for rare diseases. In June, the company closed a $30 million series A round with Fidelity and OrbiMed, and also announced a deal with Bayer AG (Xetra:BAYN) to develop and commercialize a gene therapy for hemophilia A (see BioCentury, June 30).

  • FDA panel to discuss Daiichi Sankyo's Savaysa

    FDA's Cardiovascular and Renal Drugs advisory committee will meet on Oct. 30 to discuss an NDA from Daiichi Sankyo Co. Ltd. (Tokyo:4568) for Savaysa edoxaban to prevent stroke and systemic embolic events in patients with non-valvular atrial fibrillation (AF); to treat deep vein thrombosis (DVT) or pulmonary embolism (PE); and to prevent recurrence of symptomatic venous thromboembolism (VTE).

    An MAA for the indications is under EMA review. The oral Factor Xa inhibitor is approved in Japan as Lixiana to prevent VTE after major orthopedic surgery and is under review in the country to treat non-valvular AF and for symptomatic VTE treatment.

  • University of California planning venture fund

    The University of California board of regents is set to vote on Thursday on a proposal to create an independent venture firm with up to $250 million to invest in commercial opportunities that emerge from UC system research, including labs and medical centers.

    The Office of the Chief Investment Officer of the Regents will fund the new firm, which will be called UC Ventures. Pending the board's vote, the university hopes to launch the fund by late next year.

    Recent examples of startups based on UC research include Aragon Pharmaceuticals Inc., which Johnson & Johnson (NYSE:JNJ) acquired in 2013; cancer immunotherapy company Kite Pharma Inc. (NASDAQ:KITE), which raised $146.6 million in an IPO in June; and cancer company Seragon Pharmaceuticals Inc., which the Genentech Inc. unit of Roche (SIX:ROG;OTCQX:RHHBY) bought earlier this year (see BioCentury, July 14).

  • Ribomic raises $25.7M in Japanese IPO

    Ribomic Inc. (Tokyo:4591) raised Y2.8 billion ($25.7 million) through the sale of 1.2 million shares at Y2,300 in an IPO on the Tokyo Stock Exchange's Mothers. The price values the company at Y27.8 billion ($258.3 million). Earlier this month the company said it planned to sell 1.2 million shares at Y2,000-Y2,300. The IPO was underwritten by Daiwa Securities; SMBC Nikko Securities; Mizuho Securities; Ichiyoshi; Ace; SBI Securities; and Monex.

    Ribomic's first day of trading is slated for Sept. 25. The company has a preclinical pipeline of RNA aptamers.

  • Proteon files for IPO

    Proteon Therapeutics Inc. (Waltham, Mass.) filed to raise up to $69 million in an IPO on NASDAQ underwritten by Stifel; JMP Securities; Baird; and Oppenheimer.

    In August, Proteon began Phase III testing of PRT-201 recombinant human elastase to improve arteriovenous fistula (AVF) outcomes in chronic kidney disease. Data are expected in 2017. The company expects to begin a second Phase III trial in 1H15. The compound has both Fast Track and Orphan Drug designations from FDA.

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