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.

On September 20, 2016 Exelixis, Inc. (NASDAQ:EXEL) reported an update on the timing of a key data presentation for cabozantinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark (Press release, Exelixis, SEP 20, 2016, View Source;p=RssLanding&cat=news&id=2204894 [SID:SID1234515256]). Detailed results from CABOSUN, the randomized phase 2 clinical trial of cabozantinib compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC), has been selected for the Presidential Symposium 3 session on Monday, October 10, 2016, starting at 16:30 CEST (local Copenhagen time) / 10:30 a.m. EDT / 7:30 a.m. PDT.

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The full logistical details for the CABOSUN data presentation are as follows:

Oral Presentation

[LBA30_PR] "CABOzantinib versus SUNitinib (CABOSUN) as initial targeted therapy for patients with metastatic renal cell carcinoma (mRCC) of poor and intermediate risk groups: Results from ALLIANCE A031203 Trial."

Dr. Toni Choueiri, Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA

Session: Presidential Symposium 3, Monday, October 10, 2016 – 16:30-18:10 CEST, Copenhagen room

Note: This is a National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) study.

The late-breaking CABOSUN abstract was initially slated for an oral presentation at a Proffered Paper session on Saturday, October 8, 2016. Exelixis previously announced that data from the Exelixis-discovered compounds cabozantinib and cobimetinib would be the subject of fifteen presentations at the ESMO (Free ESMO Whitepaper) 2016 Congress. For full details on Exelixis’ presence at the conference, please see the company’s press release issued on August 31, 2016.

On September 20, 2016 The Bayer Group reported that it aims to achieve further growth in the coming years and is seeking higher sales and earnings in all businesses (Press release, Bayer, SEP 20, 2016, View Source [SID:SID1234515255]). "We are optimistic about Bayer’s medium-term development and have therefore set ambitious aspirations," Management Board Chairman Werner Baumann said on Tuesday at the "Meet Management" investor conference in Cologne. "We anticipate especially significant sales and margin growth at Pharmaceuticals. This growth is expected to be driven particularly by the positive development of our recently launched products, for which we now see combined peak sales potential of more than EUR 10 billion," said Baumann. At Crop Science, Bayer expects a substantial increase in the margin after closing of the planned acquisition of Monsanto. The prospects for Consumer Health and Animal Health are positive as well.

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In the prescription medicines business (Pharmaceuticals), Bayer aspires to achieve average annual sales growth of approximately 6 percent by the end of 2018 after adjusting for currency and portfolio effects (Fx & portfolio adj.). Sales of this division totaled EUR 15,308 million in 2015 including the Radiology business. Bayer aims to increase the EBITDA margin before special items of Pharmaceuticals to between 32 and 34 percent in 2018 (2015: 30.1 percent).

Baumann raised the estimate of the combined peak annual sales potential of the five recently launched pharmaceutical products from previously at least EUR 7.5 billion to now more than EUR 10 billion. Bayer now expects peak sales potential of more than EUR 5 billion (previously: approximately EUR 3.5 billion) for the anticoagulant Xarelto; the figure for the eye medicine Eylea is now more than EUR 2.5 billion (previously: at least EUR 1.5 billion). The company anticipates peak sales potential of more than (previously: at least) EUR 1 billion for the cancer drug Xofigo and more than (previously: at least) EUR 0.5 billion for the pulmonary hypertension treatment Adempas. The peak sales potential of the cancer drug Stivarga is unchanged at at least EUR 1 billion.

"We are also very confident about our Pharmaceuticals business beyond these products," stressed Baumann. He explained that Bayer has promising product candidates in its Pharmaceuticals pipeline, six of which have combined peak sales potential of at least EUR 6 billion. This includes vericiguat to treat worsening chronic heart failure (approximately EUR 0.5 billion), finerenone for diabetic kidney disease (at least EUR 1 billion), vilaprisan against uterine fibroids (at least EUR 1 billion), BAY-1841788 (ODM-201) to combat prostate cancer (at least EUR 1 billion), anetumab ravtansine to treat various types of cancer (at least EUR 2 billion) and copanlisib to combat lymphoma (at least EUR 0.5 billion). Overall Bayer currently has 19 projects in clinical Phase III, 16 in Phase II and 15 in Phase I. "We are planning at least 20 product launches at Pharmaceuticals by the end of 2023," said the Management Board Chairman, explaining that this includes both new active substances and new indications for already approved substances.

Consumer Health aims to accelerate innovation

In the business with self-care products (Consumer Health), Bayer aims to grow average annual sales by between 4 and 5 percent (Fx & portfolio adj.) by the end of 2018 (2015: EUR 6,076 million). The company aspires to achieve a clean EBITDA margin of approximately 25 percent in 2018 (2015: 24.0 percent). In this attractive business, Bayer has a wide range of strong brands such as the analgesics Aspirin and Aleve, the antihistamine Claritin and the Bepanthen/Bepanthol wound and skin care products, Baumann explained. "At Consumer Health we want to concentrate on global brands that occupy leading positions in their respective categories and implement differentiated brand strategies tailored to the respective local markets." The focus here is on key markets such as the United States, China, Brazil and Russia, the Bayer CEO said, adding that the company aims to accelerate innovation at Consumer Health. According to Baumann, the objectives here include leveraging the growth potential offered by seeking regulatory approval for over-the-counter status for products that previously were only available with a prescription (Rx-to-OTC switches), and developing new digital health offerings for consumers.

Crop Science targeting higher margins following closing of the Monsanto acquisition

In the agricultural business (Crop Science), Bayer is aspiring above-market average annual sales growth (Fx & portfolio adj.) in the coming years, accounting for the agreed acquisition of Monsanto. Pro forma sales of the combined business of the Crop Science Division and Monsanto amounted to EUR 23.1 billion in the calendar year 2015. It is planned for the clean EBITDA margin of the combined agricultural business to reach more than 30 percent after the third year following closing of the transaction (2015 pro forma: approximately 27 percent).

"The agreed acquisition of Monsanto represents a major step forward for our Crop Science Division and reinforces Bayer’s position as a global, innovation-driven Life Science company with leadership positions in our segments," said Baumann. He explained that Bayer aims to create a leading agricultural company with an integrated offering. The broad product range and the research and development pipeline of the combined business offer better solutions for farmers’ current and future needs, he said. Over the medium to long term, the combined company will be able to accelerate innovation and provide customers with enhanced solutions and an optimized product suite based on analytical agronomic insight supported by Digital Farming applications.

Bayer and Monsanto signed a definitive merger agreement on September 14 that enables Bayer to acquire Monsanto for USD 128 per share in an all-cash transaction. The acquisition is subject to customary closing conditions, including Monsanto shareholder approval of the merger agreement and receipt of required regulatory approvals. Closing is expected by the end of 2017.

"We also want to continue growing in the Animal Health business," emphasized Baumann. Bayer aspires to grow sales of that business by between 4 and 5 percent yearly on average through the end of 2018 (2015: EUR 1,490 million). The company seeks to reach a clean EBITDA margin of between 23 and 24 percent in 2018 (2015: 23.4 percent).