On January 9, 2019 Puma Biotechnology, Inc. (the "Company") reported that it has entered into a License Agreement (the "Agreement") with Knight Therapeutics Inc. ("Knight") (Filing, 8-K, Puma Biotechnology, JAN 9, 2019, View Source [SID1234532676]).

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Pursuant to the Agreement, the Company granted to Knight, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license (i) to commercialize any product containing neratinib and certain related compounds (the "Licensed Product") in Canada (the "Territory"), (ii) to seek and maintain regulatory approvals for the Licensed Products in the Territory and (iii) to manufacture the Licensed Products anywhere in the world solely for the development and commercialization of the Licensed Products in the Territory for human use, subject to the terms of the Agreement and a supply agreement to be negotiated and executed by the parties.

Under the terms of the Agreement, the Company will be solely responsible for the manufacturing and supply of the Licensed Products to Knight, but under limited circumstances Knight may obtain the right to manufacture the Licensed Products under the supply agreement.

The Agreement sets forth the parties’ respective obligations with respect to the commercialization of the Licensed Products. Within the Territory, the Company will be solely responsible for obtaining the regulatory approval for the indication of extended adjuvant treatment of HER2-positive early stage breast cancer ("Initial Indication") and Knight will use commercially reasonable efforts to prepare, file and manage regulatory filings for any other indications in the field of human use. Promptly after obtaining the regulatory approval for the Initial Indication in the Territory, the Company will transfer such regulatory approval to Knight, and Knight will own and hold any regulatory approvals for the Licensed Products in the Territory in its name.

Pursuant to the Agreement, the Company is entitled to upfront and development milestones of up to US$2.0 million, and sales milestone payments of up to CAN$7.0 million, payable upon achievement of the milestone events specified in the Agreement. Furthermore, the Company is entitled to receive significant double digit royalties calculated as a percentage of net sales of the Licensed Products in the Territory.

The term of the Agreement continues, on a Licensed Product-by-Licensed Product basis, until the later of (i) the expiration or abandonment of the last valid claim of the licensed patents that covers such Licensed Product in the Territory, or (ii) the earlier of (x) the time when generic competitors to such Licensed Product have achieved seventy percent (70%) or more market share in the Territory based on unit volume, or (y) ten (10) years following the date of first commercial sale of such Licensed Product in the Territory. The Agreement may be terminated by either party if the other party commits a material breach, subject to a customary cure period, or if the other party is insolvent. Knight may terminate the agreement with ninety (90) days’ written notice in the event either party or both parties receive any written claim alleging that the manufacture or commercialization of the Licensed Products in the Territory infringes, misappropriates, or otherwise violates any intellectual property rights of a third party. The foregoing description of the Agreement is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019.

On January 9, 2019 Selexis SA, a pioneering life sciences company and a global leader in mammalian cell line generation technology, reported that it has signed additional commercial license agreements (CLAs) with Agenus Inc., (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, and adoptive cell therapies (Press release, Selexis , JAN 9, 2019, View Source [SID1234532600]).1 Under the new CLAs, Agenus will leverage Selexis’ modular SUREtechnology Platform for the rapid, stable, and cost-effective production of its therapeutic proteins.

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"It’s gratifying to have the opportunity to play a part in Agenus’ mission to redefine cancer treatment by advancing promising new biologics for individuals living with cancer," said Yemi Onakunle, PhD, MBA, Selexis vice president, licensing and business development. "The Selexis team has a notable track record of success in helping our partners overcome protein-expression challenges and advance products rapidly and safely through the clinic to the market where they can be made available to patients in need."

The Selexis SUREtechnology Platform improves the way mammalian cells are used in the discovery, development and manufacturing of recombinant proteins and drugs. The platform provides key significant advantages over traditional approaches, enabling: speed, high-yield, stability and flexibility.

"Our fully integrated capabilities, from early discovery of protein therapeutics to GMP manufacturing, allows us to rapidly produce and clinically test promising new drug candidates thereby delivering innovation with speed. A critical step in this process is the in-house development of commercially viable cell-lines expressing novel and complex proteins," said Alex Duncan, PhD, chief technology officer at Agenus. "We have successfully used the Selexis’ platform to drive our lead anti-CTLA4 (AGEN1884) and anti-PD1 (AGEN2034) programs, and are excited to partner with them to advance our novel single agent and multi-specific antibody programs."

On January 9, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present at the 21st Annual Needham Growth Conference in New York City on Tuesday, January 15, 2019 at 8:40 a.m. EST (5:40 a.m. PST) (Press release, Veracyte, JAN 9, 2019, View Source [SID1234532601]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On January 9, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported its 2019 financial guidance at the 37th annual JP Morgan Healthcare Conference (Press release, Halozyme, JAN 9, 2019, View Source [SID1234532605]).

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"Looking ahead, our ENHANZE business is gaining momentum with key product development milestones expected this year, including potential FDA approval of a subcutaneous formulation of Herceptin and regulatory submissions for the subcutaneous formulation of Darzalex each representing important near-term catalysts," said Dr. Helen Torley, president and chief executive officer. "In our oncology business, HALO-301 has completed enrollment and topline results are projected in the second half of 2019."

Halozyme provided an update on the 2019 outlook for its ENHANZE franchise. The company expects to make meaningful progress this year toward its projection of the potential for approximately $1 billion in royalty revenue in 2027. During the first quarter, FDA action is expected on the Biologics License Application (BLA) filed by ENHANZE partner Genentech, a member of the Roche Group, for the subcutaneous (SC) formulation of trastuzumab (Herceptin). In the second half of 2019, ENHANZE partner Janssen Biotech, Inc. anticipates filing for approval of the SC formulation of its multiple myeloma drug daratumumab (Darzalex). Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target.

By the end of 2019, the company expects three ENHANZE programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products. This accelerating partner activity supports the projection of the potential for approximately $1 billion in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be $1 billion, with $225 million to $300 million in revenues projected between 2019 and 2021.

The company also provided an update on its late stage targeted oncology asset PEGPH20. Enrollment in HALO-301, the company’s phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed at the end of 2018 with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS (overall survival) events between August and November of 2019. Based on this timeline, the company projects topline results will be available in the second half of 2019.

Halozyme and its partners continue to explore the pan-tumor potential of PEGPH20. This includes ongoing phase 1b studies in pancreas cancer, gastric cancer, gall bladder cancer and cholangiocarcinoma.

2019 Financial Guidance

The company also provided financial guidance for 2019:

Net revenue of $175 million to $185 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements.
Operating expenses of $265 million to $275 million, or $225 million to $235 million excluding an expected increase in cost of goods sold. Excluding the cost of goods sold the modest increase in expenses is driven by ENHANZE partner support, and support of the potential commercialization of PEGPH20.
Operating cash burn of $75 million to $85 million.
Debt repayment of approximately $90 million.
Year-end cash balance of $180 million to $190 million.
Table 1. 2019 Financial Guidance

Guidance Range

Net Revenue

$175 million to $185 million

Operating Expenses

$265 million to $275 million

Operating Expenses (excl. COGS)

$225 million to $235 million

Operating Cash Burn

$75 million to $85 million

Debt Repayment

~$90 million

Year-end Cash Balance

$180 million to $190 million

The company plans to report fourth quarter and full year 2018 financial results on February 21, 2019.

A replay of Dr. Torley’s presentation at the conference today can be accessed for the next 90 days via the "Investors" section of www.halozyme.com. Also, a copy of the presentation made today was filed with the Securities and Exchange Commission as part of a Form 8-K that can also be accessed via the "Investors" section of www.halozyme.com.

On January 9, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on schedule (Press release, Athenex, JAN 9, 2019, View Source;p=RssLanding&cat=news&id=2382773 [SID1234532606]). Athenex also reaffirms that top line data from the study is expected to be available in mid-2019.

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About Oraxol Phase III Study

Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor). The Oraxol Phase III study is an open-label, randomized, multicenter study to determine the safety, tolerability, and tumor response of Oraxol compared with IV paclitaxel in patients with metastatic breast cancer, with a target enrollment of 360 adult female patients. Secondary endpoints will measure progression-free survival and overall survival. More information about this study is available at www.clinicaltrials.gov.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi