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Boehringer Ingelheim enters into an exclusive license agreement with Hanmi Pharmaceutical to develop 3rd generation EGFR targeted therapy in lung cancer

On July 28, 2015 Boehringer Ingelheim and Hanmi Pharmaceutical Co. Ltd reported an exclusive license and collaboration agreement for the development and global commercialisation rights, except South Korea, China and Hong Kong, of HM61713, a novel 3rd generation EGFR targeted therapy for the treatment of EGFR mutation positive lung cancer (Press release, Boehringer Ingelheim, JUL 27, 2015, View Source [SID:1234506712]). Under the terms of the agreement Hanmi will receive an initial payment of USD 50 million and is entitled to potential milestone payments of USD 680 million plus tiered double-digit royalties on future net sales. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the U.S., and other customary closing conditions.

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Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim said, "This exclusive license agreement with Hanmi Pharmaceutical is a significant step towards our vision of providing a wide-range of lung cancer treatment options as we better understand the underlying drivers of this devastating disease. The in-licensing of a 3rd generation EGFR agent bolsters our existing lung cancer portfolio and reiterates our commitment towards improving the lives of people with cancer through innovation and tailored treatment options."

HM61713 is a novel 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI). At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, interim results of the Phase I/II clinical trial were presented and showed strong efficacy signals, combined with a favourable safety profile.1 The compound is currently in Phase II clinical development for patients with non-small cell lung cancer (NSCLC) with T790M mutations who have developed resistance to previous EGFR targeting agents. Preparations have begun for a broader Phase III trial programme, to be initiated in 2016.

HM61713 is another important pillar in Boehringer Ingelheim’s global lung cancer franchise which builds on two products, GIOTRIF/GILOTRIF (afatinib*) and VARGATEF (nintedanib**), approved in various countries. With the inclusion of HM61713, Boehringer Ingelheim now has more than 10 compounds in clinical development in a wide variety of oncology indications, including immune oncology approaches like an mRNA based therapeutic vaccine under development in collaboration with CureVac.

Dr Jeewoong Son, Chief Medical Officer of Hanmi Pharmaceutical said, "We are excited at the potential this license agreement with Boehringer Ingelheim will bring to the successful development of HM61713 and the possibilities this will offer to lung cancer patients. Boehringer Ingelheim has significant expertise in the field of lung cancer, specifically in EGFR mutated disease. Boehringer Ingelheim’s strong pipeline demonstrates its long-term commitment to successful development of cancer treatments. We are confident we have found the right partner to make the potential of HM61713 a reality."

Teva Withdraws Proposal to Acquire Mylan

On July 27, 2015 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that it has withdrawn its cash and stock proposal to acquire all of the outstanding ordinary shares of Mylan N.V. (NASDAQ: MYL) and Teva does not intend to continue to pursue a transaction with Mylan at this time (Press release, Teva, JUL 27, 2015, View Source;p=RssLanding&cat=news&id=2071089 [SID:1234506710]). Teva’s decision to terminate the proposal to acquire Mylan follows today’s announcement that Teva has entered into a definitive agreement with Allergan to acquire Allergan Generics.

"In light of our strategic acquisition of Allergan Generics, which will transform the industry, our Board and management team has decided that withdrawing the proposal to acquire Mylan is in the best interests of Teva stockholders," said Erez Vigodman, President and CEO of Teva. "Since announcing the proposal to acquire Mylan on April 21, 2015, we have appreciated the opportunity to talk with many of our investors about the future of the generics industry, and we are confident our proposed transaction with Allergan best positions Teva to succeed in today’s industry landscape."

Mr. Vigodman continued, "We continue to believe that a combination of Teva and Mylan would have made sense for our companies, our respective stockholders and the healthcare industry as a whole. However, despite our clear commitment to consummating a transaction, and our conviction that we ultimately would have succeeded in acquiring Mylan, we believe we have an even greater opportunity to create compelling, sustainable value for Teva’s stockholders through our transaction with Allergan – and we acted quickly to seize the opportunity. Our agreement with Allergan will reinforce Teva’s strategy to create an even stronger business model in the industry and will position us well to grow the business and better serve our customers and patients."

Teva intends to review its options with respect to its ownership of approximately 4.6% of the outstanding ordinary shares of common stock of Mylan.

Barclays and Greenhill & Co. are serving as financial advisors to Teva. Sullivan & Cromwell LLP, De Brauw Blackstone Westbroek N.V. and Tulchinsky Stern Marciano Cohen Levitski & Co are serving as legal counsel to Teva.

Nymox Pivotal Phase 3 NX-1207 BPH Extension Trial Successfully Meets Primary Endpoint. Company Plans to File for Regulatory Approvals for Fexapotide Triflutate (NX-1207).

On July 27, 2015 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that the Company’s U.S. long-term extension prospective double-blind Phase 3 BPH studies NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BPH have successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo (Press release, Nymox, JUL 27, 2015, View Source;fvtc=4&fvtv=6907 [SID:1234506709]). Fexapotide showed an excellent safety profile with no evidence of drug-related short-term or long-term toxicity nor any significant related molecular side effects in the 2 studies (n=978).

The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories.

The Company will present a public webinar and conference call today July 27 at 4:30 p.m. EDT (see below).

The primary endpoint variable of the long-term study was improvement in the AUA BPH Symptom Score which was statistically significant (p<.02) in fexapotide-treated patients compared to placebo, at a median duration of 42 months (3.5 years) after a single double-blind injection treatment of fexapotide vs. saline placebo. In addition, responder analysis for the primary endpoint variable met the prespecified endpoint (p<.01). All subjects from both studies with 2 years or more duration follow-up after a single painless injection were eligible, however all documented treatment failures of any duration in the studies from day 1 onward were also included in the data as treatment failures. Patients were followed double-blind up to 65 months (5.4 years) after a single injection.

Highlights of the pivotal Phase 3 extension top-line results are summarized as follows:

Median duration of 3.5 years from a single injection treatment mean improvement of 5.3 points in AUA BPH Symptom Score. Statistically significant (mean p<.025; median p<.02) vs saline placebo injection.

Mean improvement of 7.1 points in AUA BPH Symptom Score (primary endpoint variable) after median duration of 3.5 years in first-line BPH treatment of fexapotide treated subjects (p<.025 vs placebo).

Patient responder rate: Statistically significant higher proportion (64%) of long-term improved patients in AUA BPH Symptom Score (primary outcome variable) after a single injection in fexapotide treated subjects vs controls (p<.005).

Improvement of nocturia: Percentage of patients with stabilization or improvement of frequency of nocturia in fexapotide treatment superior to placebo (p<.03).

The Company also reported on new Phase 3 data of lowered incidence of surgery in patients in Phase 3 studies NX02-0020 and NX02-0022.

Reduced incidence of surgery: Subjects in Phase 3 studies NX02-0020 and NX02-0022 with 1 or 2 injections of fexapotide had statistically significant reduction of BPH surgery within 24 months of fexapotide treatment (1.7% incidence of surgery in 2 years) (p<.02 vs placebo).

In addition, the following advantages of the new drug are highlighted:

Safety profile highly superior to existing treatments. Minimal or no sexual, hormonal or cardiovascular or other debilitating side effects.

Reduced cancer risk in Phase 2 data: U.S. Phase 2 data showing therapeutic effect of fexapotide on prostate cancer. Phase 2 data showed fexapotide treated low grade localized prostate cancer (Gleason 3+3 or less) had statistically significant less progression compared to controls. By comparison, some commonly used older approved BPH treatments have been linked to increased cancer risk.

Enhanced compliance and patient convenience compared to oral medications. Fexapotide is given as a single painless office treatment injectable. Older approved oral medications generally involve daily pills intended for the rest of the patient’s life.
– See more at: View Source;fvtc=4&fvtv=6907#sthash.6hF2kWGB.dpuf

DelMar Pharmaceuticals Announces Financing Update and Initial Subscriptions of $2.0 million in Registered Direct Offering

On July 27, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, reported that it has accepted subscriptions from institutional and accredited investors for a registered direct placement ("Placement") of 3.35 million shares of common stock and 3.35 million common stock purchase warrants for aggregate purchases of $2 million (Press release, DelMar Pharmaceuticals, JUL 27, 2015, View Source [SID:1234506707]).

Each common share was purchased at a price of $0.60 per share and each common stock purchase warrant entitles the holder to purchase an additional share of the Company’s common stock at a price of $0.75 per share for a period of five years.

Included in the subscriptions announced today are $1.3 million in purchases from existing DelMar Shareholders, including $157,000 from Directors and Officers of the Company.

"We are very pleased for the continued strong support from our existing shareholders as we continue to pursue our mission to benefit patients and create shareholder value by rapidly developing and commercializing anti-cancer therapies," said Jeffrey Bacha, DelMar’s president & CEO.

DelMar will use the proceeds from this financing to support the continued clinical development of its lead product candidate, VAL-083, as a potential new treatment for refractory glioblastoma multiforme (GBM), and additional research into new indications including non-small cell lung cancer (NSCLC) and other solid tumors, and for general corporate purposes.

The securities described above have been offered pursuant to a registration statement (File No. 333-203357), which was declared effective by the United States Securities and Exchange Commission ("SEC") on July 15, 2015. Under the terms of the registration statement, the Company may issue up to 13,333,333 shares of common stock and 13,333,333 common stock purchase warrants for gross proceeds of up to $8 million. The registered offering will expire on July 31, 2015, unless extended to August 14, 2015 at the sole discretion of the Company.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there by any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Copies of the prospectus related to this offering may be obtained by clicking on the following link: View Source

Allergan Accelerates Transformation to Branded Growth Pharma Leader by Divesting Global Generics Business to Teva for $40.5 Billion

On July 27, 2015 Allergan plc (NYSE: AGN) reported that it has entered into a definitive agreement under which Teva Pharmaceutical Industries Ltd. will acquire Allergan’s global generic pharmaceuticals business for $40.5 billion (Press release, Actavis, JUL 27, 2015, View Source;p=RssLanding&cat=news&id=2071091 [SID:1234506706]). Allergan will receive $33.75 billion in cash and $6.75 billion in Teva stock. In addition, Allergan retains 50 percent of Teva’s future economics from generic lenalidomide (Revlimid). The transaction has been unanimously approved by the Boards of Directors of Allergan and Teva and is strongly supported by the management teams of both companies.

Logo – View Source

Under the agreement, Teva will acquire Allergan’s legacy Actavis global generics business, including the U.S. and international generic commercial units, third-party supplier Medis, global generic manufacturing operations, the global generic R&D unit, the international over-the-counter (OTC) commercial unit (excluding OTC eye care products) and some established international brands.

Allergan will retain its dynamic global branded pharmaceutical and medical aesthetic businesses, as well as its biosimilars development programs and the Anda distribution business.

"This transaction will accelerate Allergan’s evolution into a branded Growth Pharma leader, enable a sharpened focus on expanding and enhancing our global branded pharmaceutical business and strengthen our financial position to build on our proven track-record of value creation led by effective capital deployment," said Brent Saunders, CEO and President of Allergan.

"Allergan expects to have 2015 pro forma sales of approximately $15.5 billion, a simplified operating model and a strong position in seven therapeutic areas, including Eye Care, Gastroenterology (GI), Aesthetics, Women’s Health, CNS, Urology and Anti-infectives. Allergan will have a simplified manufacturing network of 12 plants globally, an industry-leading mid-to-late-stage R&D pipeline with 70 projects and a global commercial operating model engineered to drive double-digit branded product sales with compelling profit margins.

"The transaction results in after tax net cash and equity proceeds of approximately $36 billion that we intend to deploy to further accelerate the robust growth prospects of our branded business. We will have the potential to add scale in existing therapeutic areas, expand into new therapeutic areas and geographies and evaluate strategic transformational deals as we continue to build on our position as the most dynamic branded growth pharma company.

"Over the years, our global team of highly capable and dedicated employees has dramatically expanded our generics portfolio, capabilities and footprint, with over 220 ANDAs pending FDA approval with 74 confirmed First-to-File opportunities, creating one of the most dynamic generics businesses in the world today. While we were not actively seeking a buyer for our generics business, Teva presented an offer at a very compelling valuation that reflects and recognizes the significant value that our global generics team has generated in creating and managing a world-class generics business. As a result of the transaction, we will also obtain a minority equity interest in Teva, to share in the upside of the generic R&D pipeline we are transferring in this combination."

Leading Brand Pharmaceutical Portfolio Supported by a World-Class Sales and Marketing Organization

The new Allergan will maintain its exceptional global brand pharmaceutical business with leading positions in key therapeutic categories. The company has blockbuster franchises in Eye Care, CNS, Aesthetics, GI and Women’s Health including world-renowned brands such as BOTOX, RESTASIS, JUVEDERM, NAMENDA XR, LINZESS and LO LOESTRIN Fe among others.

The company’s experienced sales and marketing organization will continue to deliver exceptional product support and service to our customers.

Strong Commercial Presence across Global Markets

Allergan will continue to have significant international commercial opportunities in all priority therapy areas, including GI, Women’s Health and the legacy Allergan businesses. The company’s commercial presence will extend across the globe with a significant presence across the UK, Canada, Europe, Southeast Asia and Latin America and a growing footprint in the Nordics, Russia, Eastern Europe, China and India. Allergan also maintains exceptional global brand equity, industry-leading consumer marketing capabilities and strong consumer awareness of key Allergan products in global markets, including VISTABEL, RESTASIS, JUVEDERM, ASACOL, OZURDEX, OPTIVE and others.

Leading Growth Pharma R&D Pipeline

Allergan will maintain its strong commitment to R&D, with 2015 pro forma investment of approximately $1.4 billion, focused on the development of innovative and durable value-enhancing global products within our brands and biologics portfolios. Allergan has a strong record of successful drug development and currently has more than 70 innovative products in mid-to-late stage development. The company’s pipeline is strategically focused within its core therapeutic areas, with key candidates for global development in Eye Care, Aesthetics, CNS, GI, Anti-infectives, Women’s Health and Urology.

Allergan’s innovative development-focused R&D organization places an emphasis on the strategic, late-stage development of important durable products that will drive long-term value, and on being the partner of choice for new and existing development collaborations.

The Company is also planning to add significant depth across its pipeline this year with the pending acquisitions of:

Naurex, a clinical-stage biopharmaceutical company developing therapies utilizing a compelling new mechanism to target areas of significant unmet medical need in Major Depressive Disorder;
Merck’s small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists for Migraine, an intensely debilitating and immobilizing condition for patients worldwide;
Oculeve, which adds novel, complementary dry eye development programs to Allergan’s current eye care research and development programs; and
Kythera, which immediately enhances Allergan’s global facial aesthetics portfolio with the addition of KYBELLA (deoxycholic acid) injection, the first and only approved non-surgical treatment for contouring moderate to severe submental fullness, commonly referred to as double chin.

Financially Compelling Transaction

Allergan will receive $33.75 billion in cash and $6.75 billion in Teva stock. The number of shares received will be based on the 20-day volume weighted average price (VWAP) ending Friday, July 31, 2015 and will be subject to a 12-month lock-up. The transaction is expected to have minimal tax leakage of approximately 10 percent with anticipated net cash/equity proceeds of approximately $36 billion which can be deployed to accelerate the company’s growth prospects. Allergan expects to have double-digit topline growth, expanding operating margins and strong free cash flow. Allergan expects to use a portion of the sale proceeds to pay down debt, including certain credit facilities and bonds. The transaction is structured to maintain the existing bond issuer and guarantor structure and compliance with bond covenants. Teva will not assume any of the bonds. Allergan remains committed to its investment grade ratings.

Beginning with its third quarter earnings report, Allergan will report its generics business as discontinued operations and expects to provide an updated 2015 forecast by mid-to-late September.

Additional Details

The transaction contains customary conditions to closing, including antitrust clearance in the U.S. and the EU and certain other jurisdictions. Following an initial period of 15 business days, there will be no financing contingency related to the transaction. No shareholder vote is required at either Allergan or Teva. The transaction is expected to close in the first quarter of 2016.

J.P. Morgan is acting as sole financial advisor to Allergan and Latham & Watkins LLP is serving as Allergan’s lead legal advisor.