Allergan plc (NYSE:AGN) rose $18.77 to $326.98 on Monday after announcing plans to acquire Naurex Inc. (Evanston, Ill.) for $560 million up front and divest its generics business to Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) for $40.5 billion in cash and stock. Allergan said it will focus on branded growth products, including pharmaceuticals, medical aesthetics products, biosimilars and its Anda Inc. distribution business.
The Naurex deal gives Allergan rapastinel (GLYX-13), an intravenous partial agonist of the glycine site of the NMDA receptor that is slated to enter Phase III testing next year as an adjunctive treatment for major depressive disorder (MDD). Rapastinel missed its primary endpoint in a crossover Phase IIb trial last year, but Naurex has said it would design its Phase III trial to account for the longer-than-expected duration of benefit seen in the Phase IIb study (see BioCentury, Dec. 22, 2014).
Allergan will also obtain NRX-1074, a second generation NMDA receptor modulator in development to treat MDD. IV NRX-1074 has completed Phase II testing and an oral formulation is in Phase I. The parties expect the deal to close by YE15.
Prior to the acquisition, Naurex will spin out its discovery platform into a new company. Allergan will collaborate with the newco to discover and develop small molecule NMDA receptor modulators to treat psychiatric and neurologic disorders, and will have the first right to license certain candidates. Financial terms of the collaboration were undisclosed.
Naurex was spun out of Northwestern University in 2007.
Teva will acquire Allergan's generics business for $33.8 billion in cash and $6.8 billion in stock in a deal expected to close in 1Q16. Teva expects the acquisition to lead to double-digit non-GAAP EPS accretion in 2016.
Also on Monday, Teva withdrew its $40.1 billion bid for Mylan N.V. (NASDAQ:MYL).
Vitae Pharmaceuticals Inc. (NASDAQ:VTAE) dropped $0.70 to $9.68 after it said Boehringer Ingelheim GmbH (Ingelheim, Germany) will terminate for "strategic business reasons" a 2009 licensing deal for Vitae's beta-secretase inhibitor program, effective Oct. 21. Boehringer had paid Vitae $42 million -- including a licensing fee, research funding and an equity investment -- up front in the deal (see BioCentury Extra, June 15, 2009).
Boehringer will return to Vitae rights to the beta-site APP-cleaving enzyme inhibitor BI1147560/VTP-36951 and to BACE1 inhibitor BI1181181/VTP-37948.
Vitae had expected Boehringer to begin a Phase I trial of BI1147560 by YE15. Vitae CEO Jeff Hatfield said the company is still deciding whether to develop the candidate on its own or seek another partner.
Boehringer placed BI1181181 on a clinical hold in February after seeing skin reactions in a Phase I study, and shifted its focus to BI1147560. Hatfield declined to discuss next steps for BI1181181 (see BioCentury Extra, Feb. 26).
Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) CEO and director Marc Beer and COO Craig Fraser resigned. Board member Sandford Smith will be interim CEO and will assume Fraser's responsibilities. The rare disease company does not plan to fill the COO position.
Smith, who joined Aegerion's board in 2012, was EVP and president of the international group at the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY).
Aegerion gained $0.74 to $18.24 on Monday.
FDA approved Daklinza daclatasvir from Bristol-Myers Squibb Co. (NYSE:BMY) in combination with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat HCV genotype 3. BMS spokesperson Robert Perry said BMS expects to launch Daklinza within a week at a list price of $63,000 for a 12-week course.
BMS already markets the HCV NS5A protein inhibitor in the EU and Japan. Last week, BMS said it does not plan to seek U.S. or EU approval of its HCV triple regimen of Daklinza, Sunvepra asunaprevir and beclabuvir (BMS-791325) due to the "evolving competitive landscape." Sunvepra is an HCV NS3 protease inhibitor and beclabuvir is a non-nucleoside HCV NS5B polymerase inhibitor (see BioCentury Extra, July 23).
Renal company Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) named Scott Holmes CFO. Holmes was SVP of finance and investor relations at AMAG Pharmaceuticals Inc. (NASDAQ:AMAG).
Oncology company CTI BioPharma Corp. (NASDAQ:CTIC; Milan:CTIC) named Bruce Seeley EVP and chief commercial officer. He was SVP and general manager of diagnostics at NanoString Technologies Inc. (NASDAQ:NSTG).
Neurology play Pozen Inc. (NASDAQ:POZN) hired Scott Charles as SVP of finance. Charles was treasurer and VP of finance at Ikaria Inc., which Mallinckrodt plc (NYSE:MNK) acquired. Pozen expects Charles will be CFO of Aralez Pharmaceuticals plc, the company that will be created from Pozen's pending merger with Tribute Pharmaceuticals Canada Inc. (OTC:TBUFF; TSX-VLTX) (see BioCentury, June 15).
Bellerophon Therapeutics Inc. (NASDAQ:BLPH) lost $4.26 (56%) to $3.39 on Monday, bringing its market cap to $43.7 million, after the PRESERVATION I trial of its Bioabsorbable Cardiac Matrix (BCM) device (BL-1040) missed its primary endpoint.
The company said there were no statistically significant treatment differences between patients treated with BCM vs. placebo. The primary endpoint was change in left ventricular end diastolic volume index (LVEDVI) at six months compared to baseline. Bellerophon plans to present detailed results on Sept. 1 at the European Society of Cardiology meeting in London.
PRESERVATION I was designed to support European CE mark registration of BCM to prevent heart failure following an acute myocardial infarction. On a conference call, Chairman and CEO Jonathan Peacock said the company may consider an alternative development path for BCM that "could involve use in combination with emerging tissue regeneration technologies or with a more focused patient group."
Bellerophon plans to begin Phase III trials by YE15 of inhaled nitric oxide (NO) with the INOpulse DS drug delivery system to treat pulmonary arterial hypertension (PAH). The INOpulse portable device synchronizes delivery of inhaled NO with the patient's breathing pattern.
At June 30, Bellerophon had about $50 million in cash to fund the inhaled NO trial; Peacock said the company is "working on a detailed restructuring plan to that end." The company did not respond to inquiries.
Bellerophon raised $60 million in an IPO in February. It was spun out from Ikaria Inc. in 2014 (see BioCentury Extra, Feb. 13).
The company has worldwide rights to BCM from BioLineRx Ltd. (Tel Aviv:BLRX; NASDAQ:BLRX) under a 2009 deal. BioLineRx lost NIS1.84 (22%) to NIS6.50 in Tel Aviv and shed $0.39 (19%) to $1.73 on NASDAQ on Monday.
Oncobiologics Inc. (Cranbury, N.J.) raised $31 million in a venture round led by Perceptive Advisors. New investors Cormorant Global Healthcare Master Fund; Longwood Capital Partners; and venBio Select Fund also participated, as did Proximare Lifesciences Fund; OSSB Pharma Fund; and MIH Fund.
Oncobiologics is developing a pipeline of 11 biosimilars. In February, ONS-3010, its biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV), met the primary endpoints of a bioequivalence study. CEO Pankaj Mohan told BioCentury that while the candidate lags other Humira biosimilars in development, the company hopes to differentiate the asset by either improving its safety or coupling it with a device that improves administration.
leon-nanodrugs GmbH (Munich, Germany) raised EUR 18.5 million ($20.5 million) in the first close of a planned EUR 21.5 million ($23.8 million) series A round led by new investor TVM Capital Life Science. New investors Signet Healthcare Partners; LifeCare Partners; CD-Venture; Albany Private Equity Holding; and an undisclosed German family office also participated. leon-nanodrugs expects to receive the remaining EUR 3 million ($3.3 million) this year from an undisclosed Chinese company.
leon-nanodrugs uses nanotechnology to develop oral and parenteral formulations of small molecule and protein drug candidates with improved bioavailability, solubility and dissolution rates.
TVM's Hubert Birner and Stefan Fischer, Signet's James Gale, and LifeCare's Gerhard Ries will join the company's board.
Ally Bridge Group launched ABG-LB, a hedge fund of undisclosed size that will invest primarily in healthcare companies headquartered in Greater China that are listed in China or the U.S.
Chief Investment Officer Bin Li will lead the fund's investment activities, which began July 15. Li was formerly head of Asia healthcare equity research at Morgan Stanley.
Index Ventures has raised EUR 60 million ($66.5 million) toward Index Ventures Life VII, a new fund with an indefinite target size, according to an SEC filing. The firm did not respond to inquiries.
In March 2012, the firm closed Index Ventures Life VI, its first dedicated life sciences fund, at EUR 150 million ($197.2 million). GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and the Johnson & Johnson Development Corp. venture capital unit of Johnson & Johnson (NYSE:JNJ) contributed to that fund (see BioCentury, March 26, 2012).
Evercore (NYSE:EVR) hired Edmund Baxter as a senior managing director in its healthcare group. He was a senior managing director and head of west coast life sciences coverage at Bank of America Merrill Lynch.
EMA issued draft revisions of its accelerated assessment and conditional approval guidelines.
The accelerated assessment guideline now includes a more detailed explanation of how applicants may justify "major public health interest," the basis for the pathway. The document also revises the pre-submission timetable to encourage sponsors to engage in early dialogue with EMA. Sponsors would now have to indicate their intent to apply for accelerated approval six to seven months before submitting a marketing application, then submit the request two to three months rather than 10-30 days ahead of an MAA submission. The EMA's CHMP will also optimize its timetable to reach a decision within 150 days.
The conditional approval guideline clarifies the definition of unmet medical needs, making treatments eligible for the pathway if they provide a substantial improvement over existing therapies. EMA clarified how sponsors should substantiate a positive benefit-risk profile when data sets are not comprehensive, including which data can be supplied after authorization. The agency also described which data are required for annual renewal submissions.
Comments on the drafts are due Sept. 30.
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