11/15/2011
Lundbeck & Otsuka Enter Long-Term CNS Agreement, Deal Has $1.8-Billion Potential
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S recently announced they have entered into a long-term agreement for the development and commercialization of up to five innovative psychiatric and neuroscience products worldwide. The agreement covers up to five early and late-stage compounds in development. The two late-stage compounds are from Otsuka: aripiprazole depot formulation and OPC-34712. Otsuka receives the rights to enter into co-development, and eventual co-promotion following approval, of up to three compounds after Phase IIb clinical trials.
The alliance is a sales and cost share agreement. Under the terms of the agreement, Lundbeck will make an up-front payment upon signing of $200 million. Otsuka will in total receive up to approximately $1.4 billion from Lundbeck as up-front payment and development and regulatory milestone payments. With the addition of sales milestones in connection, Lundbeck will pay up to approximately $1.8 billion to Otsuka. Both companies will share the sales and development and commercialization costs based on the agreement.
For aripiprazole depot formulation, Lundbeck will receive 50% of net sales in Europe (EU5 and the 4 Nordic countries) and
For OPC-34712, Lundbeck will receive 50% of net sales in Europe (EU5 and the 4 Nordic countries) and
In co-commercialization countries, the parties will share sales efforts and costs in accordance with the territory split. In the
Otsuka brings a strong presence in the North American and Asian CNS markets, and Lundbeck complements Otsuka’s position with a strong presence in
Daiichi Sankyo to License ARQ 092 From ArQule
ArQule, Inc. and Daiichi Sankyo, Co. Ltd. recently announced the execution of a license agreement for the development of a new AKT inhibitor called ARQ 092, the first compound to emerge from the companies’ November 2008 agreement to collaborate on research utilizing the AKIP (ArQule Kinase Inhibitor Platform) technology to generate novel, selective, and potent small molecule kinase inhibitors. Under the license agreement, Daiichi Sankyo will obtain exclusive rights for development, manufacturing, and marketing of ARQ 092 on a worldwide basis.
ARQ 092 will be studied in cancer patients to identify its utility in targeting the AKT-signaling pathway, which plays a role in regulating cell growth, survival, migration, and angiogenesis, and is frequently deregulated in cancer. Patient enrollment in the Phase I clinical trial with ARQ 092 is scheduled to open in the coming months.
“ARQ 092 is a potent, selective AKT inhibitor that has been optimized through a structure-based drug design methodology developed by ArQule scientists,” said Dr. Thomas C.K. Chan, Chief Scientific Officer of ArQule. “This clinical candidate is the result of close scientific collaboration between the two companies throughout the past two-and-a-half years.”
“The ARQ 092 collaboration builds on the success of our other partnerships with ArQule, including the co-development of our c-MET inhibitor, tivantinib, which is currently being studied in a Phase III trial as a treatment for non-squamous, non-small cell lung cancer,” said Dr. Kazunori Hirokawa, Global Head of the R&D Unit of Daiichi Sankyo. “In addition to our own internal R&D capabilities, our strategic alliance partnerships, such as our collaborations with ArQule, allow us to combine forces to move more programs into clinical trials toward our common goal of improving and extending lives.”
Kinases play pivotal roles in modulating diverse cellular activities and have been implicated as important mediators of certain forms of cancer and other diseases. The AKIP technology is based on a novel binding mode that leads to inhibition of target kinases by small molecules that do not compete with adenosine triphosphate (ATP) for binding. ArQule has identified more than 200 human kinases involved in multiple therapeutic areas that are amenable to such non-ATP competitive inhibition. ArQule’s ability to rationally design novel kinase inhibitors that encompass new chemical spaces allows for an expanding intellectual property estate. The company believes that non-ATP competitive small molecule inhibitors may have fewer off-target side effects and may have utility in treating a broad range of human diseases.
Positive Phase II Results Reported for Sanofi/Regeneron Pharmaceuticals Cholesterol Drug
Sanofi and Regeneron Pharmaceuticals, Inc. recently announced positive preliminary results from the Phase II study program in which patients with elevated low-density lipoprotein cholesterol (LDL-C) were treated with REGN727/SAR236553.
REGN727/SAR236553 is a novel, high-affinity, subcutaneously administered, fully human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). Blocking the PCSK9 pathway is a novel mechanism for lowering LDL-C, the leading known risk factor for coronary artery disease.
One Phase II trial studied patients with heterozygous familial hypercholesterolemia (heFH) with elevated cholesterol (LDL-C>/=100 mg/dL) despite lipid lowering therapy (statins with or without ezetemibe). The objective of the study was to compare the effect of adding REGN727/SAR236553 to the existing lipid-lowering therapy in heFH patients. In the primary efficacy analysis of the study, after 12 weeks of treatment, patients who received different dosing regimens of REGN727/SAR236553 achieved mean LDL-C reductions from baseline ranging from approximately 30% to greater than 65%, depending on the dosing regimen of REGN727/SAR236553, compared to a mean reduction of 10% with placebo (p < 0.05 for all dose groups). Patients in the study are being followed for a total of 20 weeks for safety.
In this trial, REGN727/SAR236553 was generally well tolerated over 12 weeks. There were no elevations in LFTs >3 times the upper limit of normal (ULN) and no cases of elevated CPK reported. The most common adverse event was injection site reaction. There were no serious adverse events on active treatment. Full safety data from the 8-week post-treatment monitoring period will be presented at a future medical congress upon final analysis.
Another Phase II trial studied patients with primary hypercholesterolemia with elevated cholesterol (LDL-C>/= 100 mg/dL) who were on a stable low dose of atorvastatin (10 mg). The primary objective of the study was to compare the effect of switching to a high dose of atorvastatin alone (80 mg) versus a high dose of atorvastatin combined with REGN727/SAR236553. In the primary endpoint of the study, after 8 weeks of treatment, patients who received REGN727/SAR236553 plus atorvastatin 80 mg achieved a greater than 65% reduction in mean LDL-C compared to a mean reduction of 17% for atorvastatin 80 mg only (p < 0.001). The study also included a third arm in which REGN727/SAR236553 was added to the stable low dose of atorvastatin, and the patients achieved a greater than 65% reduction in mean LDL-C. Patients in the study were followed for a total of 16 weeks for safety.
In this trial, REGN727/SAR236553 was generally well tolerated over 16 weeks. There was one serious adverse event of dehydration in the REGN727/SAR236553 + atorvastatin 80 mg group that was deemed not treatment related. One patient in the REGN727/SAR236553 + atorvastatin 80-mg group with mildly elevated AST prior to randomization (>ULN and 3ULN and
“The preliminary Phase II results with our anti-PCSK9 antibody are very encouraging,” said Elias Zerhouni, President, Global Research & Development, Sanofi. “We look forward to analyzing and presenting the complete data set and remain committed to advancing this program into Phase III development as soon as possible.”
“Despite the availability of statins, elevated cholesterol and coronary artery disease remain a leading cause of morbidity and mortality in the
More detailed data from these Phase II trials, as well as from the third ongoing Phase II trial, will be submitted for presentation at an upcoming scientific conference.
NeuroDerm Announces Positive Phase II Results of Dermal Patch for Patients with Parkinson’s
NeuroDerm, Ltd. recently announced the results of a Phase I/II safety and pharmacokinetic trial of ND0611, administered as an adjunct therapy to Sinemet, Sinemet CR, or Stalevo, in patients with advanced Parkinson’s disease. ND0611 is a proprietary carbidopa liquid formula administered subcutaneously via a dermal patch to increase the bioavailability and efficacy of orally administered levodopa. Results of this study support the continued development of ND0611 for the treatment of Parkinson’s disease.
This double-blind, randomized, six-way crossover study met all of its primary and secondary endpoints. The analysis showed that ND0611, when compared with placebo, showed meaningful, highly statistically significant improvement in all of the pharmacokinetic (PK) endpoints when administered with three most common oral levodopa therapies (immediate-release Sinemet, Sinemet-CR, and Stalevo). The primary and secondary PK endpoints included levodopa half-life, the duration of levodopa concentration in excess of a threshold of 1000 ng/ml in plasma, the area-under-the-concentration-time-curve, and levodopa trough levels. The full results of this study will be presented at a future scientific meeting.
The most common adverse events across all treatment arms, including placebo, were vertigo, nausea, asthenia, back pain, myalgia, pain in extremity, headache, and erythema. There were no clinically relevant effects seen in laboratory measured or vital signs.
“This first trial in patients of ND0611 hit all of its endpoints and was a complete success. ND0611 is an innovative treatment for PD and this important milestone justifies ND0611’s further clinical and regulatory development,” said Sheila Oren, MD, VP Clinical and Regulatory Affairs at NeuroDerm.
“One of our priorities at MJFF is to drive research that could improve the quality of life for people living with PD today,” added Brian Fiske, PhD, Director of Research Programs at MJFF. “NeuroDerm is working to develop a therapy that might do just that. By providing a more even and continuous supply of levodopa to the brain, ND0611 has the potential to limit the motor fluctuations that many patients experience during periods when their medication wears off.”
This placebo controlled, randomized, double-blind, six-way crossover trial enrolled 24 patients with advanced Parkinson’s disease. All patients were administered the three most commonly-used levodopa therapies (previously mentioned) in 100-mg dosage four times per day; in addition they received either ND0611 or placebo.
In addition to evaluating safety and tolerability, the study’s primary endpoint was improvement in levodopa half-life in all treatment arms; secondary endpoints included additional PK parameters. All PK parameters for each oral treatment mode were evaluated separately and showed statistical significance. This trial was supported by a grant of $1 million by The Michael J. Fox Foundation for Parkinson’s Research as part of the Foundation’s Clinical Intervention Awards 2010 program.
NeuroDerm is an emerging pharmaceutical company that develops therapies for the treatment of CNS diseases. NeuroDerm’s technology is based on proprietary reformulations of well-established oral drugs whose low bioavailability is the major impediment to better efficacy.
Salix Pharmaceuticals to Acquire Oceana Therapeutics for $300 Million
Oceana Therapeutics LLC, a privately owned global company focused on commercializing best-in-class specialty therapeutics, recently announced it has entered into a definitive agreement for the sale of its operating subsidiary, Oceana Therapeutics, Inc. to Salix Pharmaceuticals, Ltd. of
“After conducting a thorough review of our strategic objectives, the Oceana management team concluded that this sale creates compelling value for all parties, including investors in both companies as well as the physicians and patients expected to benefit from the combination of Oceana’s commercial assets, Deflux and Solesta, with Salix’s strengths in gastroenterology treatments, said Gregory Stokes, Oceana’s EVP, Business Development.
Deflux is approved in the
Led by John T. Spitznagel, Oceana’s Chairman & CEO, and David S. Tierney, MD, President & COO, Oceana was founded in mid-2008 and reunited a veteran team of healthcare professionals, many who pioneered the Buy & Build, Search & Develop specialty pharmaceutical model of selectively identifying, acquiring, and developing novel prescription drugs and drug candidates.
“At Oceana, we broke new ground by greatly expanding the Buy & Build, Search & Develop model to encompass a broader range of products, including specialty medical devices as well as pharmaceuticals.” said Mr. Spitznagel. “We also broadened our sights to pursue international product opportunities, and as early as mid-2009, within a year of start-up, Oceana was generating a revenue stream through the worldwide sales of Deflux.”
“Today, Oceana is truly a global company with a sales and distribution network encompassing dozens of countries,” added Dr. Tierney. “Both John and I recognize and applaud the contributions and excellence of the entire Oceana team who have driven our company’s rapid growth and success.”
Mr. Spitznagel and Dr. Tierney first collaborated in the second half of the 1990s when they joined Roberts Pharmaceutical and spearheaded a turnaround in Roberts’ earnings into rapid growth, which, in turn, led to that company’s purchase by Shire plc in December 1999. Collectively, over the past decade, the Oceana management team has built substantial value in other specialty healthcare companies, including: ESP Pharma, acquired by PDL BioPharma; Esprit Pharma, merged into Allergan; and Valera Pharmaceuticals, now part of Endo Pharmaceuticals.
Accentia Biopharmaceuticals to Sell Analytica for $10 Million
Accentia Biopharmaceuticals, Inc. recently announced it has entered into a series of agreements to strengthen its financial position, improve its balance sheet, and support ongoing biotech development plans for its immunotherapy pipeline. The company has entered into an agreement to sell the assets of its non-strategic business unit, Analytica International, Inc., a healthcare economics consulting firm, for up to $10 million to be paid in a combination of fixed and contingent payments by the purchaser, LA-SER Alpha Group Sarl.
Upon the closing of this agreement, Accentia will sell the consulting business conducted by Analytica, which the company does not consider to be critical to its ongoing biotech development activities. Additionally, Accentia has entered into an agreement with its senior secured lender pursuant to which the company will, at closing, prepay $4 million in principal with funds made available by the asset sale and obtain a 1-year extension of all remaining principal and interest payments from its senior secured lender. Both agreements are subject to conditions precedent to closing, expected to occur prior to year-end.
“These transactions are an important part of our ongoing strategy to continue to strengthen the company’s financial position,” explained Accentia’s President and General Counsel, Samuel S. Duffey. “I consider these transactions to be both strategic and timely, as our majority-owned subsidiary, Biovest, prepares for meetings with US and international regulatory agencies to discuss the next steps required for potential approval of our personalized cancer vaccine, BiovaxID.”
Biovest has completed two Phase II clinical trials and a controlled, randomized Phase III clinical trial of BiovaxID, an autologous active immunotherapeutic cancer vaccine being developed as consolidation therapy for the treatment of follicular lymphoma and mantle cell lymphoma in first remission.
“This transaction monetizes a non-core asset in order to eliminate all short-term debt requiring payment in cash, extending all principal and interest payments to our senior secured lender into mid-to-late 2013 so that our financial obligations and resources are better aligned with our planned biotech development milestones,” added Mr. Duffey. “Based on a schedule of expected performance-based milestone payments, we expect to add, non-dilutively, up to $6 million to support our BiovaxID and Revimmune development programs. Importantly, we also secured a prepaid credit for future services from Anaytica to support our planning with regard to pricing and reimbursement strategies.”
Headquartered in
Accentia holds a majority-ownership stake in Biovest International, Inc., an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific cancer vaccine, BiovaxID, with three clinical trials completed, including a Phase III study for the treatment of follicular non-Hodgkin’s lymphoma.
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