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Xspray Pharma proposes a directed issue of 1,350,000 shares corresponding to approximately SEK 88 million to expand the product portfolio

On January 30, 2018 Xspray Pharma reported its board of directors has resolved to propose a directed share issue of 1,350,000 shares at a subscription price of SEK 65 per share, representing a discount of 2 percent compared to the volume weighted average price during the last five trading days (Press release, Xspray, JAN 30, 2018, View Source [SID1234650101]). The share issue will provide Xspray Pharma with approximately SEK 88 million before transaction costs.
The objective of the proposal and the reasons for the deviation from the shareholders’ preferential rights are to strengthen the institutional shareholder base in the company and in a timely manner enable the company to finance the development of additional product candidates, relying on positive research data published on 24 October 2017. Shareholders representing approximately 67.2 per cent of the shares of Xspray Pharma have undertaken to vote in favour of the issue, including the company’s largest shareholder Östersjöstiftelsen who will not participate in the issue. The directed issue will be fully subscribed by a number of selected investors in accordance with separate agreements, including Robur Ny Teknik, Niclas Ericsson&family, Unionen and Nyenburgh. The board of directors will convene an extraordinary general meeting to be held on 20 February to resolve on the share issue.

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NOT FOR DISTRIBUTION OR PUBLIC RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH MEASURES WOULD BE IN VIOLATION OF APPLICABLE REGULATIONS. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER, OR A SOLICITATION OF ANY OFFER, TO BUY OR SUBSCRIBE FOR ANY SECURITIES IN XSPRAY PHARMA IN ANY JURISDICTION.

"Our research results have proven that the tools we have developed are working for developing bioequivalent PKI-drugs based on our HyNap-platform. This reduces the development risk and enables us to develop additional drug candidates, efficiently and faster than anticipated by the time of the IPO last year. To be able to develop more drug candidates fast will increase our options as well as the value of the company’s product pipeline," comments Per Andersson, CEO of Xspray Pharma.

Background and reasons

The company intends to use the proceeds from the directed rights issue for financing the development of up to four new drug candidates, based on the company’s HyNap-platform. The new drug candidates will be selected out of a group of six potential drug candidates currently under evaluation. All of them have a similar profile to that of the company’s three current main candidates, i.e. they are all new versions of established cancer drugs based on protein kinase inhibitors – "PKI:s". The primary patents of the original drugs will expire between 2024-2026. The total annual sales of these original drugs in 2022 is estimated to exceed USD 7.3 billions in the US alone. The proceeds will in an efficient and timely manner enable Xspray to broaden its product portfolio of clinically proven drug candidates.

The issue

The board of directors has resolved to propose an extraordinary general meeting to resolve on a directed share issue of not more than 1,350,000 shares. The subscription price for the issue is SEK 65 per share, which, in total, will provide the company with approximately SEK 88 million before transaction costs. The subscription price for the issue has been determined through a so-called private placement procedure and represents a discount of 2 percent compared to the volume weighted average price during the last five trading days. The directed issue will be fully subscribed by a number of selected investors in accordance with separate agreements, including Robur Ny Teknik, Niclas Ericsson&family, Unionen and Nyenburgh.

Shareholders representing approximately 67.2 per cent of the shares in Xspray Pharma, including the company’s largest shareholder Östersjöstiftelsen who will not participate in the issue, have undertaken to vote in favour of the issue at the extraordinary general meeting.

The reasons for the deviation from the shareholders’ preferential rights are to strengthen the institutional shareholder base of the company, whilst in an efficiently managed and timely manner raise capital for the development of additional drug candidates. Through the issue, the share capital will increase with SEK 1,350,000 to SEK 13,706,460, which entails a dilution effect of approximately 9.8 per cent of both the number of shares and votes.

bridgebio pharma licenses late-stage oncology drug infigratinib to tackle fgfr-driven maladies; establishes new subsidiary qed therapeutics with $65 million in initial financing

On January 30, 2018 BridgeBio Pharma reported that it is has licensed infigratinib (BGJ398), a highly potent and selective inhibitor of the tyrosine kinase receptor FGFR, from Novartis (Press release, BridgeBio, JAN 30, 2018, View Source [SID1234576281]). In addition, BridgeBio announced that it was launching new subsidiary QED Therapeutics to drive development of infigratinib with an initial financial commitment of $65 million .

FGFR has been implicated as a driver mutation across multiple oncologies – including roughly one out of every five cases of cholangiocarcinoma and urothelial carcinoma – and in multiple forms of pediatric skeletal dysplasias, namely achondroplasia, which affects one out of every 20,000 live births.

Infigratinib is currently in a Phase 2 clinical trial for patients with chemotherapy-refractory bile duct cancer (cholangiocarcinoma) containing FGFR2 fusions. Early clinical results, recently published in the Journal of Clinical Oncology, demonstrated that the compound showed meaningful activity in this population.

"We are committed to moving this compound forward in late-stage development and further proving the strong efficacy in cancer that has already been demonstrated across multiple trials," said Daniel Hoth, M.D., QED’s chief medical officer, who has devoted over three decades to drug development, including time as chief of the Investigational Drug Branch of the National Cancer Institute (NCI).

Cholangiocarcinoma affects approximately 6,000 to 8,000 patients a year in the United States. Treatment options are limited, and survival rates vary depending on whether cholangiocarcinoma is found on the bile duct branches within the liver versus those outside of the liver.

"Despite immense strides in studying potential drugs in cholangiocarcinoma, there remains significant need to provide options to these patients," said Stacie Lindsey, president of the Cholangiocarcinoma Foundation. "The patients and caregivers we work with are very hopeful given data already generated with infigratinib, and we are excited that the passionate team at BridgeBio and QED are working to advance this drug."

BridgeBio co-founder and investor Frank McCormick, Ph.D., head of the NCI’s Ras initiative and former CSO and co-founder of Onyx Pharmaceuticals, remarked "Infigratinib embodies the crux of what we set out to do at BridgeBio: develop targeted therapies for genetically-driven tumors and monogenic disorders."

In addition to its clinical data in FGFR-driven cancer, infigratinib has demonstrated potential in skeletal dysplasias, including achondroplasia. In the early work published in the Journal of Clinical Investigation, researchers demonstrated that low doses of infigratinib corrected pathological hallmarks of achondroplasia in mouse models.

Neil Kumar, Ph.D., chief executive officer of BridgeBio, noted that with infigratinib, "We have a late-stage, targeted oncology compound that has demonstrated clear efficacy in the clinic. With the same molecule, we have a potential best-in-class therapy to treat achondroplasia at its source."

While specific terms of the deal have not been disclosed, BridgeBio has committed $65 million in financing to QED, which is inclusive of a substantial upfront payment to Novartis as well as equity in QED. Novartis will also receive additional payments upon the realization of development and sales milestones as well as royalties.

Alligator presents at Aktiedagen in Lund

On January 30, 2018 Alligator presented the corporate presentation (Press release, Alligator Bioscience, JAN 30, 2018, View Source [SID1234538703]).

Puma Biotechnology and Medison Pharma Enter into Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib) in Israel

On January 30, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and Medison Pharma Ltd, Israel’s leading commercial partner for innovative pharmaceuticals, reported that they have entered into an exclusive agreement under which Medison will commercialize NERLYNX (neratinib) in Israel (Press release, Puma Biotechnology, JAN 30, 2018, http://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-medison-pharma-enter-exclusive-licensing-agreement-commercializ [SID1234523630]).

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NERLYNX is not approved currently for commercialization outside of the United States. Medison will be responsible for seeking the requisite regulatory approval and, once approved, for commercializing NERLYNX in Israel. Puma will receive upfront and milestone payments throughout the term of this agreement, as well as significant double digit royalties on NERLYNX sales in Israel.

"Our new agreement with Medison demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in Israel access NERLYNX at the earliest opportunity."

"We are excited about the opportunity to provide this therapy to women in our region. We plan to expedite access to NERLYNX via an early access program. In tandem, we plan to file for marketing authorization with the Israeli Ministry of Health, and expect to receive regulatory approval for NERLYNX in Israel during the first half of 2019," said Meir Jakobsohn, Chief Executive Officer and Founder of Medison Pharma. "NERLYNX is highly complementary to our comprehensive portfolio, and will further strengthen Medison’s lead in the Israeli oncology market."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS:

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:

Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

Consolidated Financial Statements for the Third Quarter Ended December 31, 2017

On January 30, 2018 Consolidated Financial Statements for the Third Quarter Ended December 31, 2017 (Presentation, Takara Bio, JAN 30, 2018, View Source [SID1234524044]).