Ohr Pharmaceutical has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Ohr Pharmaceutical, 2017, DEC 15, 2017, View Source [SID1234522669]).

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On December 15, 2017 Ohr Pharmaceutical, Inc. (Nasdaq: OHRP), a clinical-stage pharmaceutical company developing novel therapies for ophthalmic disease, reported financial results for its fiscal year ended September 30, 2017 (Press release, Ohr Pharmaceutical, DEC 15, 2017, View Source [SID1234522662]).

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"Our primary focus at Ohr continues to be the successful completion of the MAKO study, our ongoing clinical trial being conducted to evaluate the efficacy and safety of Squalamine in combination with Lucentis for treatment-naive patients with the wet form of age-related macular degeneration (wet-AMD)," said Dr. Jason Slakter, chief executive officer of Ohr Pharmaceutical. "The MAKO study enrolled a targeted population identified in the prior Phase 2 study which we believe is best suited for Squalamine combination therapy and is consistent with the mechanism of action of Squalamine and the vascular biology of the disease. We remain on track to receive and report top-line efficacy data from the MAKO study in early calendar 2018."

Corporate Highlights for the Fiscal Year Ended September 30, 2017

● Continued progress of the ongoing clinical study in wet-AMD, entitled the MAKO study. The study is a multi-center, randomized, double-masked, placebo controlled clinical trial designed to investigate Ohr’s lead candidate Squalamine in combination with Lucentis in wet-AMD.

○ Topline data from the study are expected in early calendar year 2018.

○ In April 2017, the Company made a strategic decision to amend the MAKO study from the original agreed-upon design to enable efficacy analyses at an earlier date than originally anticipated.

○ More than 200 patients were enrolled in the MAKO study. Patients received monthly Lucentis and either topical Squalamine or placebo eye drops twice daily. The primary endpoint is an assessment of visual acuity gain at nine months.

○ The MAKO study prospectively enrolled the patient population identified from the prior Phase 2 IMPACT study that had the greatest potential to benefit from Squalamine combination therapy.

● Raised approximately $19.5 million in combined net proceeds, after deducting placement agent fees and offering expenses payable, from two public offerings of common stock and warrants that closed on December 13, 2016 and on April 10, 2017.

● In May, the Company appointed the Honorable Mike Ferguson as a Director and Chairman of the Board of Directors.

○ Mr. Ferguson served for nearly a decade in the House of Representatives. As Vice Chairman of the House health subcommittee, he led policy reforms including the creation of the Medicare Part D prescription drug benefit and pharmaceutical and medical device user fee reauthorizations. He is also Senior Advisor and Leader of the Federal Policy Team at Baker Hostetler LLP, one of the nation’s largest law firms.

Financial Results for the Fiscal Year ended September 30, 2017

● For the year ended September 30, 2017, the Company reported a net loss of approximately $23.8 million, or ($0.53) per share, compared to a net loss of approximately $25.8 million, or ($0.82) per share, in the same period of 2016.

● For the year ended September 30, 2017, total operating expenses were approximately $23.8 million, consisting of $5.3 million in general and administrative expenses, $17.4 million of research and development expenses, and $1.2 million in depreciation and amortization. This compares to total operating expenses of approximately $24.6 million, consisting of approximately $7.7 million in general and administrative expenses, $16.5 million in research and development expenses, and $1.2 million in depreciation and amortization in the same period of 2016.

● At September 30, 2017, the Company had cash and cash equivalents of approximately $12.8 million, compared to cash and cash equivalents of approximately $12.5 million at September 30, 2016.

Conference Call & Webcast
Friday, December 15th @ 8:30am Eastern Time
Domestic: 877-407-0789
International: 201-689-8562
Conference ID: 13674508
Webcast: View Source

Replays – Available through December 22, 2017
Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 13674508

On December 15, 2017 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has approved ESKATA (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses, or SKs (Press release, Aclaris Therapeutics, DEC 15, 2017, View Source [SID1234525224]). SKs are non-cancerous skin growths that affect more than 83 million American adults and can be an aesthetic skin concern. SKs tend to increase in size and number with age. The condition is more prevalent than acne, psoriasis and rosacea combined.

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"This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "For the first time, with the approval of ESKATA, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs."

ESKATA is a proprietary, high-concentration hydrogen peroxide-based topical solution designed for in-office application by a healthcare provider. It is a targeted treatment applied directly to the raised SK using a pen-like applicator.

"We are proud to offer ESKATA to dermatologists and their patients as a treatment that can clear raised SKs without cutting, burning or freezing the skin. As a clinician, I saw first-hand that patients preferred non-invasive treatments," said Stuart D. Shanler, M.D., Chief Scientific Officer of Aclaris. "We believe ESKATA may appeal to patients who are bothered by the appearance of their raised SKs — especially in highly visible areas such as the face and neck — and that patients are looking for a treatment that is safe and effective."

"Many of my patients begin to notice SKs around age 40 and feel self-conscious about them," said Anne M. Chapas, M.D., FAAD, Founder and Medical Director of Union Square Dermatology; Clinical Instructor of Dermatology, Mount Sinai Medical Center, New York; and a consultant for Aclaris. "With the approval of ESKATA, I am pleased to be able to offer my patients a topical treatment option that is well tolerated and can clear raised SKs with a low risk of scarring."

The FDA approval of ESKATA is based on two pivotal Phase 3 trials that demonstrated the safety and efficacy of ESKATA for the treatment of raised SKs. In these trials, patients received up to two treatments with ESKATA, with one at treatment initiation and a second at week three. Patients treated with ESKATA were more likely to have all four treated SKs completely cleared after two treatments than patients who received placebo. Treatment with ESKATA was generally well tolerated, with the most common side effects being itching, stinging, crusting, swelling, redness and scaling at the site of application.

It is important to see a healthcare provider with expertise in diagnosing skin conditions to confirm the diagnosis of SKs and determine whether ESKATA is an appropriate treatment.

"A recent consumer survey by the American Society for Dermatologic Surgery (ASDS) supports the need for an effective treatment of SKs," said Lisa Donofrio, M.D., ASDS President. "ESKATA provides physicians with the first topical treatment option to satisfy this unmet patient need."

ESKATA will be offered to patients as a self-pay aesthetic treatment and is expected to be commercially available in the spring of 2018. Visit www.ESKATA.com for more information and to view the full Prescribing Information. In addition, Aclaris has submitted a Marketing Authorization Application (MAA) for ESKATA for the treatment of SKs in select countries in the European Union.

Management will conduct a conference call at 8:00 AM ET today to discuss the approval of ESKATA. A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at www.aclaristx.com/events-and-webcasts. A replay of the webcast will be archived on the Aclaris website following the event.

To participate on the live call, please dial 844-776-7782 (domestic) or 661-378-9535 (international), and reference conference ID 8793369 prior to the start of the call.

Important Safety Information

ESKATA (hydrogen peroxide) topical solution, 40% (w/w) is for use as an in-office treatment. ESKATA is applied by your healthcare provider and is not for use at home.

Serious eye problems can happen if ESKATA gets into your eyes. If ESKATA accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes.

Skin reactions occurred in and around the treatment area after application of ESKATA. Some were severe, including breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring.

The most common side effects of ESKATA include itching, stinging, crusting, swelling, redness and scaling.

Tell your healthcare provider about any side effects that bother you or do not go away. Tell your healthcare provider right away if ESKATA gets into your eyes, mouth or nose during application.

Approved Use for ESKATA

ESKATA is a prescription medicine used to treat seborrheic keratoses that are raised.

You are encouraged to report negative side effects of prescription drugs to the FDA. Contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see ESKATA Full Prescribing Information and Patient Information at www.ESKATA.com.

About Seborrheic Keratoses

Seborrheic keratoses (SKs) are non-cancerous skin growths that affect more than 83 million Americans and are most commonly seen in middle-aged and older adults. SKs vary in color from flesh-colored to pink, yellow, gray, tan, brown, or black; can range in size from a millimeter to a few centimeters wide; and typically have a slightly elevated, waxy or scaly appearance. The number and size of SKs tends to increase with advancing age. SKs frequently appear in highly visible locations, such as the face or neck, but can also appear anywhere on the body, except the palms, soles and mucous membranes.

On December 15, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, is now available by prescription in Germany (Press release, TESARO, DEC 15, 2017, View Source [SID1234522658]). ZEJULA is also currently available for patients in the United Kingdom (UK) who have private insurance. On November 16, the European Commission (EC) approved ZEJULA as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response (CR) or partial response (PR) to platinum-based chemotherapy. ZEJULA is the first once-daily, oral PARP inhibitor to be approved in Europe that does not require BRCA mutation or biomarker testing.

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"As we continue to globalize our mission, we remain committed to enabling access to this important therapy for patients who have completed platinum-based chemotherapy and have limited treatment options. In the U.S., where ZEJULA has been approved since March, it is the most frequently prescribed PARP inhibitor for patients with ovarian cancer," said Orlando Oliveira, Senior Vice President and General Manager of TESARO International. "The introductions of ZEJULA in Germany and the UK are significant milestones for TESARO as we bring transformative therapies to patients with cancer around the globe. With two approved products in Europe, we are working quickly to make our medicines available in the 17 European countries where we have a direct presence."

The EC approval of ZEJULA was based on data from the clinically rigorous ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study of ZEJULA that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. The primary endpoint of the trial was progression free survival (PFS). Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by a robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients with or without germline BRCA mutations as compared to the control arm. Treatment with ZEJULA reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (hazard ratio (HR) 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.

In the ENGOT-OV16/NOVA trial, the most common grade 3/4 adverse reactions to ZEJULA included thrombocytopenia (34%), anemia (25%), neutropenia (20%), and hypertension (8%). Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low, approximately 1% after month three. The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3%, 2% and 1% of patients, respectively.

The approved starting dose of ZEJULA is 300 milligrams once per day. According to the European summary of product characteristics (SmPC), in patients below 58 kilograms, a starting dose of 200 milligrams once per day may be considered. The most commonly administered dose of ZEJULA over the course of the Phase 3 NOVA clinical trial was 200 milligrams once per day, following dose modification. Further exploratory analyses of the NOVA study indicated that individual dose modification maintained efficacy and reduced the rate of new adverse events1.

About Ovarian Cancer in Europe
Europe has one of the highest incidences of ovarian cancer in the world with approximately 45,000 women diagnosed each year2,3. In the European Union, ovarian cancer is the sixth-most common cancer and the fifth-most frequent cause of cancer death among women there2,4. Despite high initial response rates to platinum-based chemotherapy, approximately 85% of women with advanced ovarian cancer will experience a recurrence of the disease after first-line treatment5. The efficacy of chemotherapy also diminishes over time.

About ZEJULA (niraparib)
ZEJULA is a once-daily, oral poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the European Union as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in 1.4% of patients receiving ZEJULA vs. 1.1% of patients receiving placebo in the Phase 3 NOVA trial, and 0.9% of patients treated with ZEJULA in all clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Monitor complete blood counts (CBCs) weekly for the first month of treatment and modify the dose as needed. After the first month, it is recommended to monitor CBCs for the next 10 months of treatment, and periodically after this time. Based on individual laboratory values, weekly monitoring for the second month may be warranted.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Pre-existing hypertension should be adequately controlled before starting ZEJULA. Monitor blood pressure monthly for the first year and periodically thereafter during treatment with ZEJULA. ZEJULA should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the possible risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.

In clinical studies, the most common adverse reactions included: thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, abdominal pain, diarrhea, dyspepsia, urinary tract infection, fatigue/asthenia, decreased appetite, headache, dizziness, dysgeusia, palpitations, insomnia, nasopharyngitis, dyspnea, cough, and hypertension.

On December 15, 2017 Cancer Research UK reported the signing of a five-year drug-discovery collaboration between its subsidiary, Cancer Research Technology (CRT), and Celgene Corporation (link is external), to discover, develop and commercialise new anti-cancer treatments (Press release, Cancer Research UK, DEC 15, 2017, View Source [SID1234522659]).

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This arrangement represents an expansion of Cancer Research Technology’s theme-based translational model that now encompasses six industry partnerships, including this new collaboration with Celgene.

The collaboration is centred on mRNA translation, the cellular process of assembling proteins, which is a promising area of research with the potential to produce treatments that can target a fundamental characteristic of cancer cells.

Dr Iain Foulkes, Cancer Research Technology’s CEO, said: "This bold and exciting collaboration between one of industry’s leading innovators, Celgene, and CRT is part of our theme-based drug discovery approach and helps leverage our understanding of cancer biology and the needs of patients to drive the most promising discoveries into the clinic.

"This is our largest drug discovery collaboration to date and represents a major endorsement of the reputation and scale of our capacity and expertise in both drug discovery and clinical development by a leading industry partner."

Cancer Research Technology will lead drug discovery R&D activity and can progress clinical candidates through phase one trials.

Under the terms of the agreement*, Celgene will pay an upfront fee to Cancer Research Technology, and have the option to secure US rights to projects resulting from the collaboration, subject to the payment of additional option fees. Celgene will also have the option to secure Global rights to such projects at the end of phase one clinical trials, subject to the payment of additional option fees.

Cancer Research Technology can receive downstream royalties and development milestones from licensed programs.