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PharmaMar will submit NDA for lurbinectedin under accelerated approval in SCLC in the USA

On August 19, 2019 PharmaMar (MSE: PHM) reported that the FDA (Food and Drug Administration) agreed with PharmaMar’s proposal to file for accelerated approval its New Drug Application (NDA) for lurbinectedin monotherapy for the treatment of second-line SCLC (Press release, PharmaMar, AUG 19, 2019, View Source [SID1234538859]).

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The FDA’s accelerated approval program allows the submission of the registration dossier for evaluation based on investigational drug results of a Phase II study for serious conditions that satisfy an unmet medical need.

The application will be based on data from the SCLC cohort of the lurbinectedin Phase II monotherapy basket trial that enrolled a total of 105 patients at 39 centers in more than 9 countries in Western Europe and the United States. The primary endpoint of Overall Response Rate (ORR), was achieved by both the investigator and the Independent Review Committee (IRC) assessment. Secondary endpoints included Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), and safety.

PharmaMar anticipates that the NDA filing will take place in the fourth quarter of 2019.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

Deciphera Pharmaceuticals Announces Closing of Public Offering of Common Stock

On August 19, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the closing of its previously announced registered underwritten public offering (Press release, Deciphera Pharmaceuticals, AUG 19, 2019, View Source [SID1234538857]). 10,810,810 shares of the Company’s common stock at a price to the public of $37.00 per share were issued and sold in the offering. The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $400.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 1,621,621 additional shares of its common stock.

J.P. Morgan, Piper Jaffray and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds of the offering to fund: clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trials, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material; Investigational New Drug-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; and working capital purposes, including general operating expenses.

The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on October 12, 2018. The final prospectus supplement and the accompanying prospectus was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be 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.

Dr. Reddy’s Laboratories announces the launch of Versavo® (bevacizumab biosimilar) in India

On August 19, 2019 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it has launched Versavo (bevacizumab), a biosimilar of Roche’s Avastin in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer) (Press release, Dr Reddy’s, AUG 19, 2019, View Source [SID1234538855]).

Dr. Reddy’s Versavo is available in strengths of 100mg and 400mg single use vials.

Commenting on the launch, MV Ramana, CEO – India and Emerging Markets, Dr. Reddy’s Laboratories, said, "We regard the good health of our patients as our responsibility and are committed to ensure that they always have access to the medicines they need. The launch of Versavo is another step in that journey and helps strengthen our Oncology portfolio."

Dr. Raymond De Vré, Global Head, Biologics, Dr. Reddy’s Laboratories added "Versavo will help improve access to high quality therapy at an affordable cost, addressing the needs of patients with different cancers in India."

Avastin and its biosimilars had India sales of approximately INR 223 Crore MAT for the most recent twelve months ending in December 2018, according to Ipsos*.

Dr. Reddy’s now has six biosimilar products commercialized in India and various emerging markets and an active development pipeline of several biosimilar products in the oncology and immunology space.

*Ipsos India Tandem Oncology Monitor 2018

About Biosimilars

Biosimilarity means1:

That the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and,

There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

BerGenBio ASA: Results for the Second Quarter and First Half 2019

On August 19, 2019 BerGenBio reported Results for the Second Quarter and First Half 2019 (Press release, BerGenBio, AUG 19, 2019, View Source [SID1234538837]).

-Acute Myeloid Leukaemia (AML): Preliminary Phase II clinical shows promising efficacy for bemcentinib in combo with low-intensity chemo in elderly AML patients unfit for intensive therapy

– Non small cell lung cancer (NSCLC): Phase II clinical data continues to show promising clinical activity and improved overall survival, particularly in patients with AXL positive tumours including those with low or no PD-L1 expression.

– Recruitment completed for second stage Phase II bemcentinib and KEYTRUDA combo trial in patients with advanced NSCLC (BGB008)

– Private placement completed, raising gross proceeds of NOK 74.2 million

– Cash and Cash equivalents at end of Q2 2019 NOK 324.4 million

– Operating loss of NOK 52.0 million in Q2 2019 (NOK 50.7 in Q2 2018) and NOK 97.1 million in H1 2019 (NOK 105.5 H2 2018).

BERGEN, Norway, Aug. 19, 2019 /PRNewswire/ — BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces its results for the second quarter and first half 2019.

A presentation and live webcast by the Company’s management will take place today at 10.00 am CEST in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"We are pleased to report a period of continued encouraging clinical data and validation of our lead candidate bemcentinib in our AML and NSCLC programmes. We are particularly excited by the LDAC combination data in second line AML patients.

Our focus is now on refining and preparing our late stage clinical trials in light of our recent clinical data and emerging market opportunities, as we continue to leverage our significant scientific and R&D leadership to develop this potentially transformative therapy. We are committed to progressing bemcentinib through to regulatory approval and, in turn, addressing the significant unmet need among AML and NSCLC patients in order to improve outcomes for these patients and create value for stakeholders."

Operational Highlights – second quarter and first half 2019

Acute Myeloid Leukaemia (AML)

– Preliminary Phase II clinical data from AML trial presented at EHA (Free EHA Whitepaper) 24 and ASCO (Free ASCO Whitepaper) 2019

Phase II trial evaluating bemcentinib in combination with low-intensity chemotherapy in elderly AML patients unfit for intensive therapy shows promising efficacy
6 out of 14 patients receiving LDAC combination achieved an Overall Response Rate (ORR) of 43%, with encouraging duration of response – this data is still maturing.
ORR significantly higher than previously reported/historical benchmarks (18%) with single-agent low dose cytarabine
Favourable safety profile continues to be seen in LDAC combination
Initiated preparation of expansion cohort to confirm the clinical signal from bemcentinib in combination with LDAC in elderly relapse/refractory AML patients.
Non-Small Cell Lung Cancer (NSCLC)

– New clinical data from BGB324 in NSCLC presented at ASCO (Free ASCO Whitepaper) 2019

Completed recruitment for second stage of Phase II trial evaluating bemcentinib and KEYTRUDA in previously treated NSCLC patients post chemotherapy (NCT03184571 (BGB008, cohort A)
First stage previously met efficacy endpoint, and reported encouraging median overall survival of 12.2 months
Preliminary Overall Response Rate of 40% continues to be seen in patients with AXL positive tumours including those with weak or no PD-L1 expression
Encouraging safety profile continues to be seen in combination
– Initiation of additional cohort in combination with KEYTRUDA in previously treated NSCLC patients post immunotherapy (NCT03184571, BGB008, cohort B)

Completed private placement, raising gross proceeds of NOK 74 million

Net proceeds from the Private Placement to be used to advance the Company’s clinical programs in AML and lung cancer, as well as for general corporate purposes
The Private Placement attracted strong interest from existing shareholders and new specialist institutional investors
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CEST at:

Carnegie AS
Fjordalleen 16, 5. floor,
Aker Brygge,
Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

Abbisko Therapeutics Announces Initiation of Phase 1 Trial for ABSK021, its Selective CSF-1R Small Molecule Inhibitor

On August 16, 2019 Abbisko Therapeutics, a clinical-stage biopharmaceutical company focused on creating innovative medicine for unmet medical needs in China and around the world, reported that it has received regulatory approval from US FDA to initiate its Phase 1 trial for ABSK021, a CSF-1R small molecule inhibitor for treating multiple types of tumors, and expects to start dosing patients shortly (Press release, Abbisko Therapeutics, AUG 16, 2019, View Source;article_id=123 [SID1234556288]).

ABSK021 is independently discovered and developed by Abbisko Therapeutics with full intellectual property rights worldwide. It is an orally administrated, highly potent, and selective small molecule inhibitor of CSF-1R with best-in-class drug-like properties. Through CSF-1R inhibition, ABSK021 could reprogram tumor-associate macrophages (TAMs) and other immune cells, modulate tumor microenvironment, and relieve tumor immunosuppression.

Based on its mechanism of action and a large number of preclinical findings, Abbisko is advancing ABSK021 into a Phase 1 clinical study in patients with advanced malignancies and Tenosynovial Giant Cell Tumors (TGCT) where TAMs are known to be likely contributors of tumorigenesis.