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Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Glioblastoma Multiforme

On August 25, 2014 Insys Therapeutics reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM), the most common and most aggressive malignant primary brain tumor in humans (Press release Insys Therapeutics, AUG 25, 2014, View Source [SID:1234500716]).

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"We are pleased to have received orphan drug designation for this aggressive and often incurable form of brain cancer. We look forward to advancing development of this product and offering a potential efficacious treatment for patients," said Michael L. Babich, President and Chief Executive Officer.

In addition to receiving ODD, Insys has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) based in San Francisco to license CPMCRI’s patent rights related to the usage of cannabinoids for the treatment of GBM.

In concert with the aforementioned exclusive licensing agreement, Insys is collaborating with Dr. Sean McAllister at CPMCRI with respect to his pre-clinical research focusing on the ability of CBD to sensitize GBM to current standard of care chemotherapy treatment. "Based on previous research conducted with CBD to treat brain tumors, we believe that there is supportive evidence for the use of CBD as an adjunct treatment in GBM and eagerly anticipate the results from our in-vivo models to further support clinical studies in humans," said Dr. McAllister.

Insys, which has more than seven years of research and development experience in the pharmaceutical cannabinoid space, manufactures pharmaceutical dronabinol (THC) and pharmaceutical CBD, both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility, located in Round Rock, Texas. The company recently submitted a Drug Master File (DMF #28255) for its CBD active pharmaceutical ingredient and believes that it is the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities.

Insys was previously granted ODD to its pharmaceutical CBD for the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome, both rare forms of epilepsy. Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: adult epilepsy; chemotherapy-induced peripheral neuropathy; and addiction in cocaine, amphetamines and opioids. Insys intends to pursue orphan drug designation for other indications that may qualify.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as certain financial incentives that can help support its development.

Roche and InterMune reach definitive merger agreement

On August 24, 2014 Roche (SIX: RO, ROG; OTCQX: RHHBY) and InterMune, Inc. (NASDAQ: ITMN) reported they have entered into a definitive merger agreement for Roche to fully acquire InterMune at a price of US$ 74.00 per share in an all-cash transaction (Press release, Roche, AUG 24, 2014, View Source [SID:1234514754]). This corresponds to a total transaction value of US$ 8.3 billion on a fully diluted basis. This offer represents a premium of 38% to InterMune’s closing price on 22 August 2014 and a premium of 63% to InterMune’s unaffected closing price on 12 August 2014. The merger agreement has been approved by the boards of InterMune and Roche.

Under the terms of the merger agreement, Roche will commence a tender offer no later than 29 August 2014, to acquire all outstanding shares of InterMune common stock, and InterMune will file a recommendation statement containing the unanimous recommendation of the InterMune board that InterMune’s shareholders tender their shares to Roche. The transaction is expected to be neutral to core earnings per share in 2015 and accretive from 2016 onwards.

The acquisition of InterMune, a Brisbane, California based biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases, will allow Roche to broaden and strengthen its respiratory portfolio globally. InterMune’s lead medicine pirfenidone is approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada and under regulatory review in the United States. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs. Roche markets Pulmozyme and Xolair in the US and has other novel therapeutic medicines targeting respiratory diseases in clinical development.

Commenting on the transaction, Severin Schwan, CEO of Roche, said, "We are very pleased that we reached this agreement with InterMune. Our offer provides significant value to InterMune’s shareholders and this acquisition will complement Roche’s strengths in pulmonary therapy. We look forward to welcoming InterMune employees into the Roche Group and to making a difference for patients with idiopathic pulmonary fibrosis, a devastating disease."

Roche plans a smooth transition of InterMune employees and operations into the Roche organisation, ensuring readiness for an expected launch of pirfenidone in the US in 2014. Commenting on the transaction, InterMune’s Chairman, CEO and President, Dan Welch, said, "This merger recognizes the significant value created by our team’s commitment, hard work and execution for more than a decade to develop and commercialize treatment options for IPF patients and their families. Roche shares our passion and commitment to the IPF community and to ensuring that pirfenidone is available as quickly as possible to patients in the United States, pending FDA approval. Roche’s global resources and scale will not only facilitate and accelerate our ability to deliver pirfenidone to more patients around the world, but also to realize our joint vision to bring additional innovative therapies to patients with respiratory diseases."

Pirfenidone has been marketed by InterMune in the EU and Canada as Esbriet since regulatory approval in 2011 and 2012 respectively. After previous regulatory review in the USA in 2010, the Food and Drug Administration (FDA) recommended an additional Phase 3 clinical trial to support the efficacy of pirfenidone. The results of this study, the ASCEND trial, were part of the new drug application (NDA) resubmission that InterMune made in May 2014. On 17 July 2014 pirfenidone received breakthrough therapy designation from the FDA. This designation is reserved for drugs that are intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The target action date, also known as the PDUFA date, for the pirfenidone NDA is 23 November 2014.
In addition to pirfenidone, InterMune has research programmes exploring new targets and pathways that may ultimately lead to improved treatment options for people with IPF, and other fibrotic diseases.
Terms of the agreement
Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of InterMune’s common stock at a price of US$74.00 per share in cash. The closing of the tender offer will be subject to the tender of a number of shares that represents a majority of the total number of outstanding shares on a fully diluted basis. In addition, the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

Following completion of the tender offer, Roche will acquire all remaining shares at the same price of US$74.00 per share through a second step merger. The closing of the transaction is expected to take place in 2014.

Citi is acting as financial advisor to Roche and Davis Polk & Wardwell LLP is acting as legal counsel to Roche. Centerview Partners and Goldman Sachs are acting as financial advisors to InterMune and Cravath, Swaine & Moore LLP is acting as legal counsel to InterMune.

About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF inevitably causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Periods of transient clinical stability in IPF, when they occur, inevitably give way to continued disease progression. The median survival time from diagnosis is two to three years which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. IPF typically occurs in patients over the age of 45, and tends to affect slightly more men than women.

About Pirfenidone
Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On 28 February 2011, the European Commission granted marketing authorization for Esbriet (pirfenidone) for the treatment of adults with mild to moderate IPF. The approval authorized marketing of Esbriet in all 28 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. In 2011, InterMune launched commercial sales of pirfenidone in Germany under the trade name Esbriet, and Esbriet is now also commercially available in various European countries, including key markets such as France, Italy and the UK.

On 1 October 2012, Health Canada approved Esbriet for the treatment of mild to moderate IPF in adult patients. Health Canada designated Esbriet for Priority Review and completed the accelerated review according to target guidelines of 180 days. InterMune launched Esbriet in Canada in January 2013.

Pirfenidone has been marketed as Pirespa since 2008 in Japan and since 2012 in South Korea by Shionogi & Co. Ltd. Under different trade names, pirfenidone is also approved for the treatment of IPF in China, India, Argentina and Mexico.
Pirfenidone is currently under regulatory review in the United States with the FDA.

Advaxis and Merck Form Collaboration to Evaluate Investigational Combination of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer

On August 25, 2014 Advaxis reported that it has entered into a clinical trial collaboration agreement with Merck, known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis’s Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck’s investigational anti PD-1 antibody, pembrolizumab (Press release Advaxis, AUG 24, 2014, View Source [SID:1234500967]). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.

Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer treatments known as immunotherapies that are designed to enhance the body’s own defenses in fighting cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response.

"We are excited to be working with Merck. Equally as exciting is the combination potential of our Lm-LLO immunotherapy with Merck’s anti-PD-1 immune checkpoint inhibitor," commented Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers."

Under the terms of the agreement, Advaxis and Merck will collaborate to evaluate the ADXS-PSA/pembrolizumab combination as a treatment for prostate cancer. The Phase 1 part of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab, and the Phase 2 portion will assess the safety and efficacy of the combination. Advaxis will sponsor and fund the study and Merck will provide pembrolizumab. The companies will collaboratively oversee the conduct of the study, which is planned to begin in early 2015. Results from the study will be used to determine the path for further clinical development of the combination.

"Collaborations such as this are an integral part of Merck’s strategy to evaluate the potential of pembrolizumab in multiple combinations for a broad range of cancers," said Dr. Eric Rubin, vice president Oncology, Merck Research Laboratories. "We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer."

Announcement – Partnership with HANMI to Develop Oncology Drug in China

On August 22, 2014 Luye Pharma reported that the Group and Hanmi Pharm on 20 August 2014, are to co-develop Poziotinib, Hanmi’s clinical small molecule inhibitor of Pan-HER, for the treatment of cancer (Press release Luye Pharma Group, AUG 22, 2014, View Source [SID:1234500711]).
Under the terms of the Agreement, the Group is granted with the exclusive rights to develop, manufacture and commercialize Poziotinib in the Group’s name in the People’s Republic of China (‘‘China’’ or ‘‘PRC’’) while Hanmi retains the exclusive rights in all other markets. The Group and Hanmi will communicate fully based on research and development (‘‘R&D’’) data of Poziotinib in/ outside China to accelerate the commercialization of Poziotinib. The Group will run and fund the development, manufacturing and commercialization work in China, and will also make certain payments to Hanmi. The Group will apply for the approval and registration of Poziotinib with the China Food and Drug Administration and any new drug certificate issued will be under the Group’s name.

(Press release, New Amsterdam Sciences, AUG 20, 2014, View Source!news/nws17/9DB24049-C973-4C90-AC93-F7FA65CB8684/new-amsterdam-sciences-continues-pact-with-dr.-jacob-finkelstein-to-advance-pulmonary-fibrosis-research [SID:1234505520])