Puma Biotechnology to Present at J. P. Morgan Healthcare Conference

On January 3, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 12:00 Noon PST on Wednesday, January 9, at the 37th Annual J. P. Morgan Healthcare Conference (Press release, Puma Biotechnology, JAN 3, 2019, View Source [SID1234532394]). The conference will be held at the Westin St. Francis Hotel in San Francisco.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com . The presentation will be archived on the website and available for 30 days

UroGen Pharma Appoints Elizabeth (Liz) Barrett as President and Chief Executive Officer

On January 3, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, reported the appointment of Elizabeth (Liz) Barrett as President and Chief Executive Officer effective immediately (Press release, UroGen Pharma, JAN 3, 2019, View Source [SID1234532411]). She will also serve on the Company’s Board of Directors. Ms. Barrett, who will be based in New York, replaces Ron Bentsur. Mr. Bentsur will step down from his position at the Company but will continue to serve in an advisory capacity as needed to ensure a smooth transition.

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Ms. Barrett will present at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, 2019 at 10:30 a.m. Pacific Time. The event will be held in San Francisco at the Westin St. Francis.

Ms. Barrett brings over 30 years of unique experience across oncology, specialty care, surgical franchises, and consumer marketing in multiple geographic regions. Her demonstrated expertise in pharmaceutical development and commercialization of oncology products will be critical as UroGen transforms into a leading commercial-stage entity and delivers potentially paradigm-shifting products to oncology patients in the urological setting.

"Liz has proven to be an exceptional leader with a well-established track record in oncology and the vision and experience to lead UroGen as it prepares for the expected launch of UGN-101, the Company’s first potential product, in 2019," said Arie Belldegrun, M.D., FACS, Chairman of the Board of UroGen. "Through the persistence and dedication of Ron Bentsur and the team, UroGen has become a leader in uro-oncology, and has energized much needed innovation in devastating urologic diseases that are often overlooked. We thank Ron for his commitment to UroGen and are pleased to support him in his future endeavors to focus on innovative early stage life sciences companies."

Ms. Barrett was CEO of Novartis Oncology and a member of the Executive Committee of Novartis. She previously served as Global President of Oncology at Pfizer Inc. At Pfizer, she held numerous leadership positions, including President of Global Innovative Pharma for Europe, President of the Specialty Care Business Unit for North America, and President of United States Oncology. Prior to Pfizer, she was Vice President and General Manager of the Oncology Business Unit at Cephalon Inc. Ms. Barrett also worked at Johnson & Johnson. She started her career at Kraft Foods Group Inc. Ms. Barrett holds a Bachelor of Science from the University of Louisiana and a Master of Business Administration from Saint Joseph’s University.

"I’ve built a career with some of the best companies in the industry and have had the opportunity to be entrepreneurial within each of those positions. This is an opportune time to take that experience and apply it to a smaller biotech company on the cusp of transformation," said Ms. Barrett. "UroGen is well positioned to firmly establish the viability of its RTGel platform as the Company completes its first NDA submission to the FDA and prepares for potential commercialization later this year. I cannot think of a more exciting time to join UroGen and work with its outstanding team as we begin to revolutionize uro-oncology and beyond."

"I’ve had the great honor of leading UroGen through its early stages of development, its initial public offering, completed enrollment of our first pivotal trial, and now, initiation of our first rolling NDA submission," said Ron Bentsur. "I have no doubt that Liz will be a great leader during UroGen’s next stage and will have the experience needed to build on our clinical success and prepare the company for commercialization. I look forward to supporting the Company’s ongoing success."

UroGen recently announced its initiation of the UGN-101 Rolling NDA Submission to the U.S. Food and Drug Administration (FDA). The completed submission is expected in mid-2019, with potential approval anticipated in 2019. The Company plans to present the topline data in January 2019.

A live audio webcast of the J.P. Morgan presentation will be available on the Investors section of UroGen’s website www.urogen.com. A replay of the webcast will be available on the website for approximately 30 days.

Infinity To Present At 37th Annual J.P. Morgan Healthcare Conference

On January 3, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will be presenting at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, 2019, at 9:30 a.m. PST (12:30 p.m. EST) in San Francisco, CA (Press release, Infinity Pharmaceuticals, JAN 3, 2019, View Source [SID1234532427]). A live webcast of Infinity’s presentation will be accessible on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event.

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Adlai Nortye Announces Clinical Collaboration with Merck to Evaluate Adlai Nortye’s AN0025 (EP4 Antagonist) in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors

On January 3, 2019 Adlai Nortye Ltd. ("Adlai Nortye"), a global clinical-stage biopharmaceutical company reported that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada) to evaluate the combination of Adlai Nortye’s AN0025 (EP4 Antagonist) and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors (Press release, Merck & Co, JAN 3, 2019, View Source [SID1234553811]).

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Under the terms of the agreement, Adlai Nortye and Merck will collaborate in a clinical trial to evaluate the safety and preliminary efficacy of the combination of AN0025 (EP4 Antagonist) and KEYTRUDA in patients with solid tumors.

"We are excited to announce this collaboration with Merck, to help bring innovative cancer treatments to patients with unmet medical needs. AN0025 is an investigational, oral EP4 antagonist – potentially first-in-class – with high activity and high selectivity," said Carsten Lu, CEO of Adlai Nortye. "Based on preliminary results, it is well tolerated in patients with solid tumors. This collaboration is supported by our recent preclinical data demonstrating the potential ability of AN0025 (EP4 Antagonist) to rescue patients who do not initially respond to anti-PD-1 therapy alone or who are resistant to PD-1 inhibitors with solid tumors."

"With its proposed mechanism of action and observed preclinical results, we believe that AN0025 (EP4 Antagonist) will become a key component in furthering the development of our oncology pipeline," said Dr. Lars Birgerson, CDO and CEO of Adlai Nortye USA. "In preclinical studies, AN0025 (EP4 Antagonist) combined with radiotherapy, chemoradiotherapy and with immune checkpoint inhibitors demonstrated antitumor activity in different malignancies, we are optimistic that the combination of AN0025 (EP4 Antagonist) with KEYTRUDA may provide meaningful clinical benefit in patients with solid tumors."

Pacira Reports Preliminary 2018 Net EXPAREL® Sales of $331 Million

On January 3, 2019 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported preliminary unaudited EXPAREL (bupivacaine liposome injectable suspension) net product sales of $94 million for the fourth quarter of 2018 and $331 million for the full-year, as compared to $79 million and $283 million reported for the fourth quarter and full-year 2017, respectively (Press release, Pacira Pharmaceuticals, JAN 3, 2019, View Source [SID1234532376]). The company previously guided to full-year EXPAREL net product sales of $325 to $330 million.

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"We are very pleased with our 2018 results, with fourth quarter EXPAREL sales exceeding our expectations and marking the highest quarterly revenues ever reported by Pacira," said Dave Stack, chairman and chief executive officer of Pacira. "With an expanding number of payers, providers and patients recognizing the value of EXPAREL as a critical component within opioid-sparing pain management strategies, we are entering 2019 with strong momentum. Our robust partnership network also remains a core driver as we continue to focus on maximizing the value of EXPAREL, including its role in transitioning certain inpatient procedures to the ambulatory setting. We are particularly excited by new reimbursement codes, which went into effect on January 1, 2019, that we believe will meaningfully expand patient access through a product-specific C-code for ambulatory surgery centers and a procedure-based D-code for the oral surgery setting.

Looking ahead, we have put in place a number of growth initiatives that include building a pipeline of innovative non-opioid pain management and regenerative health solutions. Our goal is that these, coupled with our unique experience and position in the marketplace as a leader in non-opioid postsurgical pain management, will make a key contribution in confronting the current U.S. pain and opioid crises."

The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s fourth quarter and full-year financial results for 2018. Pacira expects to report its complete financial results for 2018, along with financial guidance for 2019, during the company’s fourth quarter earnings call, which will take place in the first quarter of 2019.