On September 20, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy (Press release, Puma Biotechnology, SEP 20, 2016, View Source [SID:SID1234515515]).

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"The FDA acceptance of our NDA is an important regulatory milestone," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need to further reduce the risk of recurrence and improve outcome following trastuzumab therapy. We believe that neratinib may be able to provide this type of improvement to further help patients with this disease. We look forward to working with the FDA during their review of this submission."

The submission is supported by the results of the ExteNET Phase III study, in which treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year invasive disease free survival (DFS) rate for the neratinib arm was 93.9% and the 2-year invasive DFS rate for the placebo arm was 91.6%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.51, p = 0.001). For the patients with hormone receptor positive disease, the 2-year invasive DFS rate for the neratinib arm was 95.4% and the 2-year invasive DFS rate for the placebo arm was 91.2%.

Results of the study were published online in The Lancet Oncology on February 10, 2016.

The most frequently observed adverse event for the neratinib-treated patients was diarrhea, with approximately 39.9% of the neratinib-treated patients experiencing grade 3 or higher diarrhea (1 patient (0.1%) had grade 4 diarrhea). Patients who received neratinib in the ExteNET trial did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea. In patients with HER2-positive early stage breast cancer who have previously been treated with adjuvant trastuzumab and received anti-diarrheal prophylaxis with loperamide, interim results of a Phase II study of neratinib monotherapy demonstrated that treatment with prophylactic loperamide reduced the rate of grade 3 or higher diarrhea to between 13.0% and 18.5%.

About ExteNET

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer. The trial randomized 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial. The primary endpoint of the trial was invasive DFS.

On September 21, 2016 BioNTech AG, a fully integrated private biotechnology company developing personalized cancer immunotherapies, reported that it will enter into a worldwide strategic collaboration with Genentech, a member of the Roche Group, to develop, manufacture and commercialize novel messenger RNA (mRNA)-based, individualized cancer vaccines (Press release, BioNTech, SEP 20, 2016, View Source [SID:SID1234515277]). The collaboration will combine Genentech’s leading cancer immunotherapy portfolio and research program with BioNTech’s proprietary mRNA cancer vaccine technology platform, and personalized medicine expertise. Together, the two companies will develop individually tailored cancer immunotherapies against a broad range of cancers to potentially provide a new treatment paradigm for cancer patients.

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The collaboration will focus on the development of mRNA cancer vaccines targeting neoantigens, based upon BioNTech’s Individualized Vaccines Against Cancer (IVAC) MUTANOME clinical platform for the potential treatment of multiple cancers. A patient’s cancer genome can be rapidly sequenced with next generation technology to define a spectrum of unique mutations known as "neoantigens" or "neoepitopes" present in a particular patient’s tumor (the "mutanome"). An mRNA vaccine encoding selected neoepitopes can be manufactured for each individual tumor’s mutanome signature, which may trigger an immune response highly specific to the tumor resulting in precisely targeted cancer cell death.

Initial clinical development will focus on combination studies using IVAC MUTANOME in a variety of cancer types.

Under the terms of the agreement Genentech will pay BioNTech $310 million in upfront and near-term milestone payments. The two companies will equally share all development costs and any potential profits for certain programs under the agreement. BioNTech has the right to co-promote certain products that arise from the agreement in the United States and certain countries, including Germany and other major European markets. Under certain circumstances, BioNTech may have sole commercialization rights for other products that Genentech elects not to commercialize. BioNTech will manufacture mRNA cancer vaccines for clinical studies. Genentech will manufacture mRNA cancer vaccines for commercial supply and BioNTech will have the right to manufacture commercial product as part of the global supply network.

Professor Dr. Ugur Sahin, CEO of BioNTech AG commented: "We are delighted to collaborate with a leading cancer immunotherapy company such as Genentech. Supported by its extensive tumor immunology understanding, BioNTech has been building clinical experience with its proprietary mRNA vaccines in a number of cancer types over several years. Combining BioNTech’s broad proprietary capabilities in the design, formulation, manufacturing and clinical testing of individualized neoantigen-based mRNA vaccines with Genentech’s eminent cancer immunotherapy, diagnostic, manufacturing and commercial expertise, will allow us, on a global scale, to drive forward the development of individualized vaccines to the market to treat a broad range of cancers. "

Sean Marett, COO of BioNTech added: "This alliance underpins BioNTech’s strategy of collaborating with companies that are committed to developing truly disruptive immunotherapies and its long term ambitions of bringing its own products to market ."

"Unlike any medicine we have ever developed, virtually all cancer patients may potentially benefit from a custom built cancer vaccine," said James Sabry, M.D., Ph.D., Senior Vice President and Global Head of Genentech Partnering. "By collaborating with BioNTech on this cutting edge approach, we hope to truly advance cancer treatments by using a common molecular backbone – mRNA – that is uniquely tailored to an individual patient."

BioNTech will continue to develop its non-neoepitope mRNA cancer vaccines outside of the collaboration.

The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to occur in the fourth quarter of 2016.

On September 20, 2016 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, reported that they have entered into a definitive agreement under which Allergan will acquire Tobira for an upfront payment of $28.35 per share, in cash, and up to $49.84 per share in Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones, for a total potential consideration of up to $1.695 billion (Press release, Allergan, SEP 20, 2016, View Source [SID:SID1234515266]). The Boards of Directors of both companies have unanimously approved the transaction.

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NASH is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.ii NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer and eventual liver failure.ii

The acquisition adds Cenicriviroc (CVC) and Evogliptin, two differentiated, complementary development programs for the treatment of the multi-factorial elements of NASH, including inflammation, metabolic syndromes and fibrosis, to Allergan’s global Gastroenterology R&D pipeline.

"The acquisition of Tobira is a strategic R&D investment within a white space area of our global Gastroenterology franchise and an opportunity to advance the development of novel treatments for NASH," said Brent Saunders, CEO and President of Allergan. "With the increasing rates of diabetes, obesity and other metabolic conditions in the U.S. and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society. It is important that we invest in new treatments today so that healthcare systems, providers and patients have treatment options to face this challenge in the coming years."

"With this acquisition, Allergan will now have one of the strongest portfolios of development stage programs for the treatment of NASH, with Cenicriviroc as the cornerstone. We will continue to look for differentiated development-stage assets that can bolster this position and enhance our commitment to innovation in this disease," added Saunders.

Cenicriviroc (CVC) is a first-in-class, once-daily, oral Phase 3 ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. In the Phase 2b CENTAUR study, CVC demonstrated a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, one of two key secondary endpoints, after one year of treatment.

The acquisition also adds Evogliptin, an oral DPP-4 (Dipeptidyl peptidase-4) inhibitor for the potential treatment of NASH. Evogliptin is being studied in a Phase 1 trial assessing the safety, tolerability and steady-state pharmacokinetic parameters of the compound when administered with and without CVC. In NASH, increased DPP-4 serum levels and hepatic DPP-4 expression is correlated with disease severity.

"Both the CVC and Evogliptin programs provide highly differentiated compounds that can make a significant impact in the treatment of NASH, where today there are no approved therapies available for patients," said David Nicholson, Chief Research & Development Officer, Allergan. "Importantly, NASH treatment may well require a multi-therapeutic approach to address the multiple factors of the disease. CVC has been shown in clinical trials to provide significant improvement in liver fibrosis, the hallmark of NASH. Liver fibrosis is associated with key long-term outcomes, including overall mortality, liver transplantation and liver-related events. Evogliptin, in preclinical models, has been shown to decrease hepatic glucose production, improve hepatic triglyceride content and steatosis, and reduce histologic markers of inflammation of the liver. Together, these programs provide a highly complementary potential therapeutic approach to address the inflammatory, metabolic and fibrotic elements of NASH that the medical community will need to treat this condition."

"I am extremely excited to see Tobira and Allergan come together," said Laurent Fischer, M.D., Chief Executive Officer, Tobira Therapeutics. "The combination of our team’s innovation in the NASH space and the infrastructure, development expertise and world-class ability of Allergan to market medicines will enable us to more rapidly develop and commercialize needed medications for patients suffering from NASH and other serious fibrotic diseases around the world."

"We are delighted that cenicriviroc will be rapidly advancing into Phase 3 studies under the stewardship of Allergan, an industry leader with world class capabilities in advancing novel treatment options to patients across the globe, and I look forward to the future success of this partnership," added Dennis Podlesak, Chairman of the Board of Tobira.

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Tobira common stock for $28.35 per share, plus one Contingent Value Right to receive up to $49.84 per share in future payments based on the successful completion of certain development, regulatory and commercial milestones. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Tobira common stock. Holders of approximately 36 percent of the outstanding shares of Tobira common stock have entered into an agreement to tender their shares into the tender offer. The merger agreement contemplates that Allergan will acquire any shares of Tobira that are not tendered into the offer through a second-step merger, which will be completed as soon as practicable following the closing of the tender offer. Pending approvals, Allergan anticipates closing the transaction by the end of 2016.

Covington & Burling LLP is serving as Allergan’s lead legal counsel. Centerview Partners and Citi are serving as financial advisors to Tobira and Skadden, Arps, Slate, Meagher & Flom LLP and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP are serving as Tobira’s legal counsel.

On September 20, 2016 Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported financial results for its fourth quarter and fiscal year ended June 30, 2016 (Filing, Q4/Annual, Palatin Technologies, 2015, SEP 20, 2016, View Source [SID:SID1234515261]).

Significant Highlights
● Bremelanotide – Under development for Hypoactive Sexual Desire Disorder (HSDD):
– Palatin’s two Phase 3 clinical trials for the treatment of HSDD randomized a total of approximately 1,250 women to evaluate efficacy and safety of subcutaneous bremelanotide in premenopausal women with HSDD as an on-demand, as-needed treatment.
– Patient enrollment was completed in the fourth quarter of calendar year 2015.
– Last patient visits for the efficacy portion of the trials were completed in the third quarter of calendar year 2016.
– Topline results are projected to be released early fourth quarter calendar year 2016.
– Issued a key U.S. Patent on May 31, 2016 for methods of treating female sexual dysfunction using the dose and formulation utilized in the Phase 3 trials. The patent expires no earlier than November 2033.
● Financial Transactions:
– August 2016, Palatin closed on an underwritten offering of units with gross proceeds of $9.25 million, with net proceeds, after deducting offering expenses, of approximately $8.5 million. Palatin issued:
■ 11,481,481 shares of common stock and ten-year prefunded Series I warrants to purchase 2,218,045 shares of common stock at an exercise price of $0.01 per share
■ Series H warrants to purchase 10,274,646 shares of common stock at an exercise price of $0.70 per share
– July 2015, Palatin closed on a debt and equity financing with gross proceeds of $30 million, with net proceeds, after deducting offering expenses, of $29.7 million, consisting of:
■ $10 million venture loan, which includes an interest-only payment period for the first eighteen months of a four year secured term loan, and Series G warrants to purchase 549,450 shares of common stock at an exercise price of $0.91 per share
■ $20 million private placement of Series E warrants to purchase 21,917,808 shares of common stock at an exercise price of $0.01 per share and Series F warrants to purchase 2,191,781 shares of common stock at an exercise price of $0.91 per share

● Intellectual Property:
– Issue Notification for U.S. Patent to issue October 4, 2016, with composition of matter claims for a broad group of melanocortin peptides.
– U.S. Patent issued September 20, 2016 with composition of matter claims for a broad family of melanocortin receptor-1 peptides with potential application in inflammatory disease-related and autoimmune indications.

Fourth Quarter and Fiscal Year Ended 2016 Financial Results
Palatin reported a net loss of $(13.4) million, or $(0.09) per basic and diluted share, for the quarter ended June 30, 2016, compared to a net loss of $(12.1) million, or $(0.09) per basic and diluted share, for the same period in 2015. The difference between the three months ended June 30, 2016 and 2015 was primarily attributable to the increase in expenses relating to the Phase 3 clinical trial and development program with bremelanotide for HSDD in the quarter ended June 30, 2016.

For the year ended June 30, 2016, Palatin reported a net loss of $(51.7) million, or $(0.33) per basic and diluted share compared to a net loss of $(17.7) million, or $(0.15) per basic and diluted share for the year ended June 30, 2015. The increase in net loss for the year ended June 30, 2016, compared to the net loss for the year ended June 30, 2015 was primarily attributable to the increase in development costs for the progression of the Phase 3 clinical trials and development of bremelanotide for HSDD and secondarily related to the license and contract revenue recognized in the year ended June 30, 2015.

Revenue
There were no revenues recorded in the quarter or year ended June 30, 2016 or in the quarter ended June 30, 2015. For the year ended June 30, 2015, Palatin recognized $12.9 million of license and contract revenue under the agreement with Gedeon Richter.

Operating Expenses
Operating expenses for the quarter ended June 30, 2016 were $12.7 million, compared to $11.8 million for the comparable quarter of 2015. For the year ended June 30, 2016, Palatin incurred $49.3 million of operating expenses, compared to $30.2 million for the year ended June 30, 2015. The increase in operating expenses for the quarter and the year ended June 30, 2016 was the result of an increase in expenses primarily relating to the Phase 3 clinical trial and development program with bremelanotide for HSDD.

Other Income/Expense
Total other income (expense), net, was $(0.6) million for the quarter ended June 30, 2016, compared to $(0.3) million for the quarter ended June 30, 2015. For the year ended June 30, 2016, total other income (expense), net, was $(2.5) million, compared to $(0.9) million for the year ended June 30, 2015. Total other income (expense) for both fiscal years ended June 30, 2016 and June 30, 2015 primarily consists of interest expense related to the venture debt. The increase in total other income (expense), net, for the year ended June 30, 2016 is due to the additional July 2015 venture debt.

Cash Position
Palatin’s cash, cash equivalents and investments were $9.4 million as of June 30, 2016, compared to cash and cash equivalents of $27.3 million at June 30, 2015. Current liabilities were $14.0 million as of June 30, 2016, compared to $7.4 million as of June 30, 2015.

Palatin believes that existing capital resources, together with approximately $8.5 million received from the August 2016 financing, will be adequate to fund our planned operations through the quarter ending December 31, 2016. Assuming the double blind efficacy portion of the Phase 3 clinical trial of bremelanotide for HSDD is successful, as to which there can be no assurance, we will need additional funding to complete required ancillary studies and clinical trials, prepare and submit regulatory filings for product approval, and establish commercial scale manufacturing capability.

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On September 20, 2016 Varian Medical Systems (NYSE: VAR) reported it will be exhibiting and demonstrating its latest radiotherapy and radiosurgery treatment, care coordination and analytics technologies and software September 25-27 in Boston, MA at the 2016 American Society for Radiation Oncology (ASTRO) Annual Meeting, booth 5063 (Press release, Varian Medical Systems, SEP 20, 2016, View Source [SID:SID1234515257]). The company also will be hosting its users meeting on Saturday, September 24 prior to the ASTRO meeting.

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Some of the Varian solutions highlighted in booth demonstrations will include:

InSightive 1.2 analytics solution which now supports both radiation and medical oncology data analytics for more informed decision making in the clinic
A new cloud-based software platform to make multi-disciplinary oncology care coordination simpler and smarter
High definition radiosurgery technology designed to improve dose conformality with the tumor and simplify dose delivery
ProBeam proton therapy system, the first fully-integrated image-guided IMPT (intensity-modulated proton therapy) solution for adaptive therapy
The Varian users meeting will provide attendees with new insights on the latest Varian technology. User meeting topics include:

Non-coplanar SRS treatment planning
The value of knowledge-based planning
InSightive analytics for streamlining clinical workflow
Velocity software and multi-modality imaging and therapy for enhanced decision-making
Proton therapy
Combination therapy: Radiotherapy and Immunotherapy
Evidenced-based oncology care
A complete user meeting agenda can be viewed at View Source

The Varian exhibit in Booth #5063 at the Boston Convention and Exhibition Center will be open during show hours from 10:00am to 5:00pm Sunday through Tuesday.