On February 19, 2016 Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicine that address major unmet medical needs, reported fourth quarter and full year 2015 financial results and highlighted recent corporate progress (Filing, 8-K, Heron Therapeutics, FEB 19, 2016, View Source [SID:1234509115]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Corporate Progress:

In February 2016, Heron successfully demonstrated bioequivalence of HTX-019 to intravenous (IV) fosaprepitant in a study that included 100 healthy volunteers. In this study, HTX-019 demonstrated a substantially improved safety profile compared to IV fosaprepitant, which contains polysorbate 80. HTX-019, a polysorbate 80-free, IV formulation of the neurokinin-1 (NK1) receptor antagonist aprepitant, is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).

In February 2016, Heron initiated a placebo-controlled, dose-finding, Phase 2 clinical trial of HTX-011 for the treatment of post-operative pain in approximately 100 patients undergoing abdominoplasty. HTX-011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam formulated with Heron’s Biochronomer drug delivery technology.

In January 2016, the U.S. Food and Drug Administration (FDA) informed Heron that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release and was unable to take action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. The FDA stated that it is targeting taking action in late February 2016.

"While we were disappointed that the FDA was unable to complete the review of the SUSTOL NDA by the original January 2016 PDUFA goal date, we appreciate the work of the FDA and remain confident in the potential of SUSTOL as an important option for the prevention of CINV in patients with cancer," commented Barry D. Quart, Chief Executive Officer of Heron Therapeutics. "Earlier this month, we achieved important milestones for our pipeline programs. We confirmed bioequivalence for HTX-019 compared with IV fosaprepitant and showed substantially improved tolerability of HTX-019, our polysorbate 80-free, IV formulation of aprepitant. In addition, we initiated our third Phase 2 study of HTX-011, which is evaluating HTX-011 in patients undergoing abdominoplasty."

Results of Operations

As of December 31, 2015, Heron had approximately $131.2 million in cash, cash equivalents and short-term investments, compared to $72.7 million as of December 31, 2014. The net increase in cash, cash equivalents and short-term investments was primarily due to Heron’s June 2015 public equity offering that resulted in total net proceeds to us of approximately $128.2 million, partially offset by net cash used in operating activities in 2015. Based on current operating plans and projections, Heron believes that its current working capital is sufficient to fund operations through 2016.

Heron’s net cash used for operating activities for the quarter and year ended December 31, 2015 was $23.2 million and $78.5 million, respectively, compared to net cash used for operating activities of $12.9 million and $60.3 million, respectively, for the same periods in 2014.

Heron’s net loss for the quarter and year ended December 31, 2015 was $31.2 million and $97.6 million, or $0.87 per share and $2.95 per share, respectively, compared to a net loss of $20.6 million and $76.4 million, or $0.71 per share and $2.87 per share, respectively, for the same periods in 2014.

The increases in net cash used for operating activities and net loss in 2015 as compared to 2014 were primarily due to costs incurred in preparation for the commercial launch of SUSTOL, as well as clinical and manufacturing costs related to our Phase 1 and Phase 2 clinical studies for HTX-011 and costs associated with the development of HTX-019.

On February 19, 2016 eFFECTOR Therapeutics, Inc., a biopharmaceutical company developing selective translation regulators for the treatment of cancer, reported it has increased its Series B financing to a total of $56M (Press release, eFFECTOR Therapeutics, FEB 19, 2016, View Source [SID:1234509106]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new funding came from Sectoral Asset Management, a new investor in the syndicate, as well as existing investors. In conjunction with the increase, eFFECTOR has appointed Maha Katabi, Ph.D., CFA, partner, private equity at Sectoral Asset Management, to its board of directors. These developments further position eFFECTOR to pursue comprehensive clinical development of its lead product candidate, eFT508, a potent, highly selective, and orally bioavailable MNK1 and MNK2 inhibitor, across multiple tumor types. The funds will also be used to advance the company’s discovery pipeline addressing additional targets.

eFT508 is currently being evaluated in an open-label Phase 1/2 trial in patients with advanced solid tumors. The company expects to file a second IND for eFT508 in lymphoma in the first half of 2016 and open expansion arms in specific solid tumors as well as lymphoma. The company also plans to declare its second development candidate later this year.

"Cancer has proven to be a very difficult disease," said Steve Worland, Ph.D., president and CEO of eFFECTOR. "If we are going to bring more effective therapy to patients, we need to think strategically about new approaches to treatment. Translation regulation targets such as MNK1 and MNK2, which simultaneously regulate multiple cancer-driving and immune-signaling pathways, are an ideal way to pursue this need. With this financial backing, eFFECTOR can make significant progress developing eFT508 and the remainder of our pipeline."

Added Dr. Katabi, "Sectoral selects investments in healthcare companies developing products that can make a meaningful impact on the patients and healthcare systems they serve. Translation control is one of the most intriguing fields of research in oncology. We are very pleased to work with the experienced team of eFFECTOR to make eFT508 the first pharmacological treatment to affect the gene translation machinery, and develop a drug useful to patients with different types of cancer."

On February 19, 2016 Novartis reported that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to PKC412 (midostaurin)(Press release, Novartis, FEB 19, 2016, View Source [SID:1234509105]). PKC412 (midostaurin) is an investigational treatment for adults with newly-diagnosed AML who are FLT3 mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard induction and consolidation chemotherapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Breakthrough Therapy designation for PKC412 (midostaurin) is primarily based upon the positive results from the Phase III RATIFY (CALGB 10603) clinical trial. This study was conducted in partnership with the Alliance for Clinical Trials in Oncology and presented during a plenary session at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting[4].

Patients who received PKC412 (midostaurin) and standard induction and consolidation chemotherapy experienced a significant improvement in overall survival (OS) (hazard ratio = 0.77, P = 0.0074) compared to those who received standard induction and consolidation chemotherapy alone[4]. The median OS for patients in the PKC412 (midostaurin) treatment group was 74.7 months (95% confidence interval [CI]: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group[4]. No statistically significant differences were observed in the overall rate of grade 3 or higher hematologic and non-hematologic adverse events in the PKC412 (midostaurin) treatment group versus the placebo group[4]. A total of 37 deaths were reported, with no difference in treatment-related deaths observed between groups[4].

"For more than 25 years, medical developments have been limited for AML patients and the chemotherapy treatment strategy has essentially remained unchanged," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "We look forward to working closely with the FDA to bring PKC412 (midostaurin), the first potential AML targeted therapy, to patients as quickly as possible."

According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions, if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program[5].

This designation adds to the growing number granted to Novartis by the FDA, illustrating the company’s continued commitment to developing innovative therapies for diseases with a significant unmet medical need.

In the US, about 20,000 people were diagnosed with AML in 2015, the majority of whom were adults[6]. According to the latest research, approximately one-third of AML patients also harbor a FLT3 gene mutation[7], which is associated with worse outcomes and shorter survival than in those without the mutation[8]. PKC412 (midostaurin) is the first drug targeting FLT3 to demonstrate an overall survival benefit in AML[4].

Since PKC412 (midostaurin) is investigational at this time and is expected to be submitted for FDA approval, Novartis opened a Global Individual Patient Program (compassionate use program) and a US Expanded Treatment Protocol (ETP) to enable PKC412 (midostaurin) access. Patients 18 years of age and older with newly-diagnosed FLT3-mutated AML and able to receive standard induction and consolidation therapy will be considered.

In order to help identify patients who may have a FLT3 mutation and potentially benefit from treatment with PKC412 (midostaurin), Novartis is collaborating with Invivoscribe Technologies, Inc. who is leading regulatory submissions for a companion diagnostic.

About acute myeloid leukemia (AML) and the FLT3 mutation
AML is an aggressive cancer of the blood and bone marrow[9]. It prevents white blood cells from maturing, causing an accumulation of "blasts" which do not allow room for the normal blood cells[9]. AML is the most common acute leukemia in adults, but also has the lowest survival rate[1]. AML accounts for approximately 25% of all adult leukemias worldwide, with the highest incidence rates occurring in the United States, Europe and Australia[1].

Mutations in specific genes are found in many cases of AML, and biomarker testing is considered standard of care for newly-diagnosed patients to help determine the best possible treatment option[7]. FMS-like tyrosine kinase-3 (FLT3) is a receptor tyrosine kinase, a type of cell-surface receptor, which plays a role in the proliferation, or increase, in the number of certain blood cells[10].

About PKC412 (midostaurin)
PKC412 (midostaurin) is an investigational, oral, multi-targeted kinase inhibitor in development for the treatment of patients with AML with a FLT3 mutation. The safety and efficacy profile has not been fully established. There is no guarantee that PKC412 (midostaurin) will become commercially available.

PKC412 (midostaurin) is also being investigated for the treatment of aggressive systemic mastocytosis/mast cell leukemia.

On February 19, 2016 Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicine that address major unmet medical needs, reported fourth quarter and full year 2015 financial results and highlighted recent corporate progress (Press release, Heron Therapeutics, FEB 19, 2016, View Source;p=RssLanding&cat=news&id=2140951 [SID:1234509102]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Corporate Progress:
In February 2016, Heron successfully demonstrated bioequivalence of HTX-019 to intravenous (IV) fosaprepitant in a study that included 100 healthy volunteers. In this study, HTX-019 demonstrated a substantially improved safety profile compared to IV fosaprepitant, which contains polysorbate 80. HTX-019, a polysorbate 80-free, IV formulation of the neurokinin-1 (NK1) receptor antagonist aprepitant, is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).

In February 2016, Heron initiated a placebo-controlled, dose-finding, Phase 2 clinical trial of HTX-011 for the treatment of post-operative pain in approximately 100 patients undergoing abdominoplasty. HTX-011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam formulated with Heron’s Biochronomer drug delivery technology.

In January 2016, the U.S. Food and Drug Administration (FDA) informed Heron that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release and was unable to take action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. The FDA stated that it is targeting taking action in late February 2016.

"While we were disappointed that the FDA was unable to complete the review of the SUSTOL NDA by the original January 2016 PDUFA goal date, we appreciate the work of the FDA and remain confident in the potential of SUSTOL as an important option for the prevention of CINV in patients with cancer," commented Barry D. Quart, Chief Executive Officer of Heron Therapeutics. "Earlier this month, we achieved important milestones for our pipeline programs. We confirmed bioequivalence for HTX-019 compared with IV fosaprepitant and showed substantially improved tolerability of HTX-019, our polysorbate 80-free, IV formulation of aprepitant. In addition, we initiated our third Phase 2 study of HTX-011, which is evaluating HTX-011 in patients undergoing abdominoplasty."

Results of Operations

As of December 31, 2015, Heron had approximately $131.2 million in cash, cash equivalents and short-term investments, compared to $72.7 million as of December 31, 2014. The net increase in cash, cash equivalents and short-term investments was primarily due to Heron’s June 2015 public equity offering that resulted in total net proceeds to us of approximately $128.2 million, partially offset by net cash used in operating activities in 2015. Based on current operating plans and projections, Heron believes that its current working capital is sufficient to fund operations through 2016.

Heron’s net cash used for operating activities for the quarter and year ended December 31, 2015 was $23.2 million and $78.5 million, respectively, compared to net cash used for operating activities of $12.9 million and $60.3 million, respectively, for the same periods in 2014.

Heron’s net loss for the quarter and year ended December 31, 2015 was $31.2 million and $97.6 million, or $0.87 per share and $2.95 per share, respectively, compared to a net loss of $20.6 million and $76.4 million, or $0.71 per share and $2.87 per share, respectively, for the same periods in 2014.

The increases in net cash used for operating activities and net loss in 2015 as compared to 2014 were primarily due to costs incurred in preparation for the commercial launch of SUSTOL, as well as clinical and manufacturing costs related to our Phase 1 and Phase 2 clinical studies for HTX-011 and costs associated with the development of HTX-019.

On February 19, 2016 The board of directors of Abbott (NYSE: ABT) reported a quarterly common dividend of 26 cents per share(Press release, Abbott, FEB 19, 2016, View Source [SID:1234509101]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This marks the 369th consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable May 16, 2016, to shareholders of record at the close of business on April 15, 2016.

Abbott has increased its dividend payout for 44 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for 25 consecutive years.