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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

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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10-Q – Quarterly report [Sections 13 or 15(d)]

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Champions Oncology, 2017, DEC 15, 2017, View Source [SID1234522666]).

Genoptix to Acquire Rosetta Genomics for $10 Million in Cash

On December 15, 2017 Genoptix, Inc., a leading oncology diagnostic laboratory, and Rosetta Genomics Ltd. (NASDAQ: ROSG), a genomic diagnostics company that improves treatment decisions by providing timely and accurate diagnostic information to physicians, reported that they have entered into a definitive merger agreement under which Genoptix will acquire all of the outstanding shares of Rosetta Genomics for a total gross purchase price of $10 million (Press release, Rosetta Genomics, DEC 21, 2017, View Source [SID1234522760]). After deducting expected payments for outstanding debt, convertible debentures, warrant termination payments, professional fees, expenses and other items, this purchase price equates to an amount that is preliminarily estimated to be $0.60, in cash, for each ordinary share of Rosetta Genomics outstanding at closing. Genoptix is a portfolio company of Ampersand Capital Partners and 1315 Capital.

Genoptix is also providing a secured bridge loan facility of up to $1.8 million to fund the operations of Rosetta Genomics through the closing of this transaction.

This merger has been unanimously approved by the Board of Directors of both companies, and the closing is expected to occur during the first quarter of 2018, subject to approval by Rosetta Genomics’ shareholders and customary closing conditions. In connection with the proposed transaction, Rosetta Genomics intends to file a proxy statement with the Securities and Exchange Commission ("SEC"). Shareholders of Rosetta Genomics are urged to carefully review the proxy statement, when available, because it will contain important information about the proposed transaction and the estimated closing purchase price for each ordinary share.

Upon closing, trading in shares of Rosetta Genomics on the Nasdaq Capital Market will cease, and Rosetta Genomics will become a wholly owned subsidiary of Genoptix.

"After a comprehensive review of strategic alternatives that included financings, acquisitions, mergers, asset monetization and corporate partnerships, we determined that this proposed transaction with Genoptix is in the best interest of all Rosetta Genomics stakeholders, including our equity holders. Our current cash position is sufficient to fund operations only until the end of 2017, and given our current market capitalization, potential for pending delisting from the Nasdaq Capital Market and the difficult financing environment for microcap molecular diagnostics companies, we do not believe we could raise sufficient capital to continue as a going concern for an extended period of time," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

"As a leader in cancer diagnostics with a more significant infrastructure, Genoptix is in a position to deploy the resources necessary to accelerate the growth of RosettaGX Revealä ("Reveal"), as well as add our solid tumor testing services to their existing product portfolio," added Mr. Berlin.

Joseph M. Limber, President and Chief Executive Officer of Genoptix, said, "The acquisition of Rosetta Genomics will broaden our product offering in oncology diagnostics, particularly in the solid tumor area. We believe that there is a significant opportunity in the diagnosis of thyroid cancer utilizing Reveal and we intend to leverage our world-class commercial capabilities to become a leader in this space. Furthermore, Rosetta’s cutting edge microRNA-based technology will be the foundation of many more diagnostic tests to be incorporated into Genoptix’ oncology portfolio."

Cantor Fitzgerald is serving as financial adviser to Rosetta Genomics on this transaction.

Chi-Med Initiates Fruquintinib U.S. Clinical Trials

On December 15, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers (Press release, Hutchison China MediTech, DEC 15, 2017, View Source [SID1234522665]). The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.

About Fruquintinib Development in China

Colorectal cancer: The China Food and Drug Administration ("CFDA") acknowledged acceptance of the New Drug Application ("NDA") for fruquintinib for the treatment of patients with advanced colorectal cancer ("CRC") in June 2017. Fruquintinib was subsequently awarded priority review status in view of its significant clinical value, according to a CFDA announcement in September 2017. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held on June 5, 2017 (clinicaltrials.gov identifier NCT02314819). The FRESCO study followed an initial Phase I trial in 40 solid tumor patients, a Phase Ib study in 62 CRC patients, and a Phase II clinical trial in 71 CRC patients.

Lung cancer: Fruquintinib is being studied in a Phase III pivotal trial in approximately 520 third-line non-small cell lung cancer ("NSCLC") patients, known as the FALUCA study (clinicaltrials.gov identifier NCT02691299), following a Phase II clinical trial in 91 third-line NSCLC patients. Fruquintinib is concurrently being studied in a Phase II study in combination with Iressa (gefitinib) in first-line setting for patients with advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116).

Gastric cancer: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol (paclitaxel), known as the FRUTIGA study, for the treatment of over 500 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma (clinicaltrials.gov identifier NCT03223376).

In China, fruquintinib is jointly developed with Eli Lilly and Company.

About Fruquintinib

Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as chemotherapy and other targeted therapies, which are being studied in our ongoing clinical trials of fruquintinib.

At an advanced stage, tumors secrete large amounts of vascular endothelial growth factor ("VEGF"), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.

Aclaris Therapeutics Receives FDA Approval for ESKATA™ (Hydrogen Peroxide) Topical Solution, 40% (w/w) for the Treatment of Raised Seborrheic Keratoses (SKs)

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.