On January 8, 2018 Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, reported certain unaudited preliminary fourth quarter 2017 financial results (Press release, IsoTis, JAN 8, 2018, View Source [SID1234522937]).

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The company expects reported revenue for the fourth quarter 2017 to be approximately $365 million, an increase of over 40% compared to $255.7 million for the fourth quarter of 2016. The strong results in the fourth quarter were driven by outperformance in both the Derma Sciences and Codman Neurosurgery acquisitions, as well as higher than expected organic growth, including improved performance in dural repair.

"We closed the year with strong performance in revenue and adjusted earnings per share," said Peter Arduini, Integra’s president and chief executive officer. "This performance resulted from higher organic sales growth in both of our divisions and a faster recovery in our Puerto Rico manufacturing facility. We expect that this top-line performance will result in adjusted earnings per share above the high-end of our guidance range for the fourth quarter."

The company is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2018 at 3:30pm PT (6:30pm ET). A live audio webcast of the presentation will be available on the Investor section of the company’s website at www.integralife.com

The company will report its final, audited fourth quarter and full year 2017 financial results during a conference call in late February 2018. A press release with the date, time and webcast information will be provided closer to the reporting date.

On January 6, 2018 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that the Company will be presenting at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Dr Reddy’s, JAN 8, 2018, View Source [SID1234522935]).

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Alok Sonig, Executive Vice President and Head, North America will present on Tuesday, January
9, 2018 at 2 p.m. (PST) [3:30 a.m. IST on January 10, 2018].

Presentation material will be available on the Company’s website www.drreddys.com

On January 7, 2018 Shanghai Sinobioway Sunterra Biotechnology (SSSB) and F1 Oncology reported the signing of new development, manufacturing, and supply agreements with plans to complete a new cGMP manufacturing facility in Shenzhen in support of large scale lentivirus contract manufacturing (Press release, EXUMA Biotechnology, JAN 7, 2018, View Source [SID1234619679]). The new facility, Shenzhen Biowit, which will expand from the current clinical production staff and site in Shenzhen, is scheduled for completion in 2018 and will utilize F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology and processes. The Shenzhen Biowit facility, in collaboration with F1 Oncology’s Hong Kong affiliate, will support future China gene therapy markets with clinical and commercial cGMP lentivirus for CAR-T and other gene therapies.

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The new collaboration agreements between F1 Oncology’s international affiliates and Sinobioway Sunterra Biotechnology will facilitate clinical development and commercialization of F1 Oncology’s CCT3-based conditionally active biologic chimeric antigen receptor T cell (CAB-CAR-T) products in China, Hong Kong, Macau, and Taiwan. F1 Oncology retains rights to CCT3 products in all other territories and exclusive responsibility for global manufacturing and supply of certain product classes.

Upon SSSB’s closing of certain financing activities, SSSB will issue to F1 Oncology 20% equity plus 5% warrants. F1 Oncology will be responsible for lead generation, preclinical safety assessment and clinical virus manufacturing costs. Sinobioway Sunterra Biotechnology will be responsible for cGMP cell processing, clinical development, regulatory approval, and commercialization in the defined territories.

The agreement provides for certain licensing fees to be paid by SSSB upon nomination of new CAR-T products with preclinical packages delivered to SSSB for commercialization. The agreement further provides for processing of raw materials provided by F1 Oncology’s international affiliates and production to supply commercial products to the China markets.

"Biowit, a subsidiary of SSSB, has been providing the majority of cell therapy research institutions in China with virus products service over the past 7 years. Today, the introduction of F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology marks a new stage of China clinical virus manufacturing. Through our one year-old collaboration, Sunterra is leveraging the value of F1 Oncology’s CAB-CAR-T technology and proprietary industrial manufacturing processes to begin novel CAR-T clinical trials in China. We are confident that F1 Oncology’s differentiating technologies will allow us to stand out from other players in the CAR-T solid tumor space." Stated Mr. Wu Zili, Board Director and founder of SSSB.

"Reliable supply of viral gene vectors for cell and gene therapy programs is a current and growing challenge for the commercial biotechnology industry, and generally requires a different facility configuration to those used for traditional biologics" stated Tim Mayall, Ph.D. Head of Process Development at F1 Oncology. "Our early investments in the generation of serum-free well-characterized cell substrates capable of suspension-based lentivirus production supports a scalability that we believe will be beneficial from first in human through commercialization."

On January 7, 2018 Celgene Corporation (NASDAQ:CELG) and Impact Biomedicines reported the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera (Press release, Celgene, JAN 7, 2018, View Source [SID1234522934]). Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.

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Fedratinib, a highly selective JAK2 kinase inhibitor, was evaluated in 877 patients across 18 clinical trials. In a randomized, placebo-controlled, phase III pivotal trial (JAKARTA-1) for patients with treatment-naïve myelofibrosis, fedratinib demonstrated statistically significant improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively. In an exploratory subgroup analysis, these improvements were observed regardless of a patient’s baseline platelet count.

A multi-center, single-arm phase II trial (JAKARTA-2) evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor. In this second-line setting, fedratinib demonstrated clinically meaningful improvements in splenic response and total symptom score.

As previously reported, JAKARTA-2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration (FDA) after potential cases of Wernicke’s encephalopathy (WE) were reported in eight out of 877 patients receiving one or more doses (less than one percent of treated patients). The FDA removed the clinical hold in August 2017.

Based on the reported benefit risk profile of fedratinib from the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory applications in myelofibrosis are planned beginning in the middle of 2018.

"Myelofibrosis is a disease with high unmet medical need as the number of patients who are ineligible for or become resistant to existing therapy continues to increase," said Nadim Ahmed, President, Hematology and Oncology for Celgene. "We believe fedratinib is uniquely positioned as a potential treatment for myelofibrosis and it provides strategic options for us to build leadership in this disease with luspatercept and other pipeline assets."

"We launched Impact Biomedicines and based on our thorough review of the data, fedratinib presents a compelling risk benefit profile in both treatment-naïve patients and patients who are resistant or intolerant to other JAK2 therapies," said Dr. John Hood, Chief Executive Officer of Impact. "We believe Celgene is the ideal organization to follow through on our mission of maximizing fedratinib’s potential for patients with myelofibrosis."

Deal Terms

Under the terms of the agreement, Celgene will make an upfront cash payment of approximately $1.1 billion. In addition, Impact Biomedicines’ shareholders are eligible to receive contingent payments based on regulatory approval and sales-based milestones. The maximum aggregate amount payable for regulatory approval milestones is $1.4 billion relating to approvals for myelofibrosis and other indications. Starting from global annual net sales of $1.0 billion, aggregate tiered sales-based milestone payments could total a maximum of $4.5 billion if global annual net sales exceed $5.0 billion.

Credit Suisse acted as financial advisor and Hogan Lovells acted as legal counsel to Celgene on the transaction. PJT Partners acted as exclusive financial advisor and Latham & Watkins acted as exclusive legal counsel to Impact Biomedicines on the transaction. The acquisition is subject to customary closing conditions and applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act. The transaction is expected to close in the first quarter of 2018.

On January 7, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, reported that Christopher O’Brien, M.D., Chief Medical Officer, has notified the Company he plans to retire in February 2018, after a transition period with his successor (Press release, Neurocrine Biosciences, JAN 7, 2018, View Source;p=RssLanding&cat=news&id=2325239 [SID1234522940]). Dr. O’Brien joined Neurocrine in 2005, and has led the clinical development and medical affairs activities for more than 12 years. Dr. O’Brien will remain as an exclusive consultant for Neurocrine.

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"On behalf of the board, shareholders and our employees, I want to thank Chris for his tremendous contributions as Chief Medical Officer of Neurocrine," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With his considerable expertise and leadership, we successfully developed and obtained FDA approval of INGREZZA capsules for the treatment of adults with tardive dyskinesia and advanced our clinical development programs for Tourette syndrome, Parkinson’s disease, endometriosis and congenital adrenal hyperplasia. I am very pleased that Chris will continue to be a part of the Neurocrine team for the foreseeable future."

Eiry W. Roberts, M.D., will join the company as Chief Medical Officer, effective January 8, 2018.

"We are very pleased to welcome Eiry to Neurocrine as she brings extensive senior leadership and pharmaceutical management experience to the team," Dr. Gorman said. "Eiry’s strong background in implementing strategic clinical development programs and navigating the regulatory approvals process across phases of drug development from research to commercialization in multiple therapeutic areas, including neuroscience, will be valuable as we execute on our commercialization and clinical plans and advance our pipeline in support of our commitment to relieve patient suffering and enhance lives."

Dr. Roberts has over 25 years of research and development experience in the pharmaceutical industry across all phases of drug development from research through commercialization in multiple therapeutic areas, including neuroscience, inflammation, oncology and metabolic diseases. She joins Neurocrine from Eli Lilly and Company where she held various positions during her tenure, including Vice President, Clinical Pharmacology and Vice President of R&D, BioMedicines Business Unit.

Dr. Roberts was the Chair of the Medical Review Committee, where she was responsible for review and approval of all the integrated clinical plans for molecules in the Lilly portfolio. She was also a member of Lilly’s Corporate Portfolio Management Committee and Lilly Ventures Steering Committee. Dr. Roberts was accountable for early clinical development programs across all therapeutic areas within Lilly, as well as registration for new chemical entities and biproducts in Phase III development. During her time at Lilly, Dr. Roberts established a new therapeutic area, which resulted in the development of five potential novel medicines from Phase I through to approval, with two of them successfully receiving regulatory approval. Dr. Roberts also has extensive leadership and business development experience, including the management of strategic alliances, business partnerships and venture capital collaborations.

Dr. Roberts is a physician who trained in pharmacology and medicine in the UK, qualifying from the University of London in 1987. Her post-graduate clinical training was in clinical pharmacology and cardiology at St. Bartholomew’s Hospital and the Royal London Hospital.

Neurocrine also announced the grant of an inducement award to Dr. Roberts pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. In connection with her employment by Neurocrine, Dr. Roberts will be granted an inducement award consisting of a stock option to purchase 70,000 shares of Neurocrine common stock. The stock option will vest over a period of four years, with 25% vesting on the first anniversary of its grant date and the balance vesting each month over the remaining three years. Dr. Roberts also received 20,000 restricted stock units which vest in equal increments over four years, with 25% vesting each year. These awards are subject to the terms and conditions of Neurocrine’s Inducement Plan, and will be effective on January 8, 2018. The stock option grant will have an exercise price equal to the closing price of Neurocrine’s common stock on the NASDAQ Global Select Market on that date. These awards were granted as an inducement material to Dr. Roberts’ employment pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.