Celltrion Begins Global Phase 3 Clinical Trial for Its Bevacizumab Biosimilar ‘CT-P16’

On August 10, 2018 -Celltrion, Inc. (KRX:068270) reported is set to launch global Phase 3 clinical trial for its bevacizumab biosimilar ‘CT-P16’ for the treatment of cancer (Press release, Celltrion, AUG 10, 2018, View Source [SID1234528713]).

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Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently submitted its Clinical Trial Application for Phase 3 clinical study to the National Authority of Medicines and Health Products, I.P. (Infarmed) of Portugal.

Beginning with Portugal, Celltrion is set to conduct Phase 3 clinical trial for CT-P16 in about 150 sites in some 20 nations across Europe, Asia and South America.

Meanwhile, Roche’s Avastin, the originator of CT-P16, is a therapeutic anti-cancer drug for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma. It last year recorded global sales of about USD 6.7 billion1, making it blockbuster medicine.

"We are successfully conducting the clinical trial for the bevacizumab biosimilar ‘CT-P16’ as planned. We will secure the competitiveness for CT-P16 compared with its competitive biosimilars." says an official of Celltrion.

1 Source: Roche Financial Report 2017

Adamis Pharmaceuticals Announces Second Quarter 2018 Financial Results and Business Update

On August 10, 2018 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the second quarter ended June 30, 2018 and a business update (Press release, Adamis Pharmaceuticals, AUG 10, 2018, View Source [SID1234528712]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Recently, we have announced several significant achievements for our company. The Sandoz partnership for the commercialization and distribution of Symjepi in the U.S. will likely prove to be the most transformative for the Company. Under the agreement, Sandoz will take responsibility for sales and marketing. We believe the financial terms of the agreement could provide for a meaningful recurring revenue to Adamis. We have also expanded our pipeline with our sublingual tadalafil (Cialis) product candidate, which is in development."

Dr. Carlo added, "The successful underwritten public offering of common stock has provided the necessary resources to advance our pipeline. We were fortunate to have had multiple fundamental health care funds lead that offering. These recent advancements have put Adamis in a strong position for growth."

Company Highlights and Product Updates

Some of the company’s product updates and accomplishments since the beginning of the second quarter of 2018 include the following:

Symjepi (epinephrine) Injection 0.30mg – The company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell Symjepi in the U.S. Key terms include: Sandoz to pay a supply price to Adamis for product, Adamis 50% profit split and Sandoz right of first negotiation for territories outside the U.S.;
APC-8000 (sublingual tadalafil) – The company is developing a new fast-dissolving sublingual tablet containing tadalafil (Cialis) and intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) with the goal of filing a New Drug Application (NDA) before year-end;
APC-6000 (naloxone) – We continue to advance our naloxone product candidate for opioid overdose, and plan to file an NDA with the FDA before year-end. This is our second product using our FDA-approved injection device;
APC-1000 (beclomethasone) – The FDA cleared Adamis to begin Phase 3 pivotal studies with our beclomethasone metered dose inhaler and we are planning to begin patient recruitment in Q4;
APC-4000 (fluticasone) – Fluticasone will be our first product candidate using our patented dry powder inhaler device platform purchased from 3M. We continue to work on proof of concept studies with the objective of demonstrating proper dosing of the steroid;
Balance sheet – We strengthened our cash position with an underwritten equity offering that raised net proceeds of approximately $37.6 million.
Second Quarter Financial Results

Revenues were approximately $3.9 million and $3.8 million for the three months ended June 30, 2018 and 2017, respectively. The increase in revenues for the three months ended June 30, 2018 compared to the comparable period of 2017 reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations resulting in part from price increases and marketing personnel efforts.

Net loss from operations for the three months ending June 30, 2018 and 2017, respectively, was approximately $9.7 million and $4.9 million. The increase in net loss primarily resulted from an increase in both selling, general and administrative ("SG&A") expenses and research and development ("R&D") expenses.

SG&A expenses for the three months ended June 30, 2018 and 2017 were approximately $6.4 million and $5.7 million, respectively. The increase was primarily due to adding personnel, increases in compensation and benefits expense, as well as, increases in the cost of maintaining licenses, registrations and intellectual property.

R&D expenses were approximately $4.8 million and $1.2 million for the three months ended June 30, 2018 and 2017, respectively. The increase was the result of the expense of advancing several late-stage candidates in our product pipeline.

At June 30, 2018, the Company had cash and cash equivalents of $4.4 million. On August 6, 2018, the Company announced the closing of an underwritten public offering resulting in net proceeds of approximately $37.6 million.

Future Milestones for 2018

Commercial launch of Symjepi (epinephrine) Injection 0.3mg in the U.S. – timing of launch and commercial strategy will be at Sandoz’s sole discretion;
FDA approval of lower dose Symjepi (epinephrine) Injection 0.15mg;
Announcement of ex-U.S. strategy for Symjepi;
Filing an NDA for naloxone injection;
Filing an NDA for the sublingual tadalafil (Cialis) tablet;
Commencement of Phase 3 studies for beclomethasone in asthmatics;
Growing net revenue of outsourcing facility (U.S. Compounding) by 30% over 2017.

Omeros to Present at the 2018 Wedbush PacGrow Healthcare Conference

On August 10, 2018 Omeros Corporation (NASDAQ: OMER), reported that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 2018 Wedbush PacGrow Healthcare Conference in New York next week (Press release, Omeros, AUG 10, 2018, View Source;p=RssLanding&cat=news&id=2363283 [SID1234528663]). The presentation is scheduled for Tuesday, August 14, 2018 at 2:30 p.m. EDT.

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The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the company’s website at www.omeros.com.

Loxo Oncology Announces Accepted Abstracts at the IASLC 19th World Conference on Lung Cancer

On August 10, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that abstracts from its LOXO-292 and larotrectinib programs have been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer to be held September 23-26, 2018, in Toronto, Canada (Press release, Loxo Oncology, AUG 10, 2018, View Source [SID1234528661]).

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The LOXO-292 oral presentation will provide an updated analysis of patients with RET fusion non-small cell lung cancer (NSCLC) enrolled in the dose escalation cohorts of the ongoing LIBERTTO-001 Phase 1/2 clinical trial. The larotrectinib poster will provide an analysis of patients with TRK fusion NSCLC enrolled to the larotrectinib clinical program.

The schedule for the presentations is as follows:

LOXO-292 Oral Presentation Session Date & Time: September 25, 2018, 3:15-4:45 p.m. ET
Title: Clinical Activity of LOXO-292, a Highly Selective RET Inhibitor, in Patients with RET Fusion+ Non-Small Cell Lung Cancer
Abstract Number: 13922
Session Title: Novel Therapies in MET, RET and BRAF
Presenter: Geoffrey R. Oxnard, M.D.

Larotrectinib Poster Presentation Session Date & Time: September 24, 2018, 9:45 a.m.-6:00 p.m. ET
Title: Rapid, Robust and Durable Responses to Larotrectinib in Patients with TRK Fusion Non-Small Cell Lung Cancer
Abstract Number: 14528
Session Title: Targeted Therapy
Presenter: Anna F. Farago, M.D., Ph.D.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

About Larotrectinib
Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated a 75 percent centrally-assessed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. The majority of all adverse events were grade 1 or 2.

Larotrectinib has been granted Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology are jointly developing the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com/trk-trials.

About TRK Fusion Cancer
TRK fusion cancer occurs when a neurotrophic tyrosine receptor kinase (NTRK) gene fuses with another unrelated gene, producing an altered tropomyosin receptor kinase (TRK) protein. The altered protein, or TRK fusion protein, is constantly active, triggering a permanent signal cascade. These proteins become the primary driver of the spread and growth of tumors in patients with TRK fusion cancer. TRK fusion cancer is not limited to certain types of cells or tissues and can occur in any part of the body. NTRK gene fusions occur in various adult and pediatric solid tumors with varying prevalence, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas.

Only sensitive and specific tests can reliably detect TRK fusion cancer. Next-generation sequencing (NGS) can provide a comprehensive view of genomic alterations across a large number of genes. Fluorescence in situ hybridization (FISH) can also be used to test for TRK fusion cancer, and immunohistochemistry (IHC) can be used to detect the presence of TRK protein.

Momenta Pharmaceuticals Reports Second Quarter 2018 Financial Results

On August 9, 2018 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) reported its financial results for the second quarter ended June 30, 2018 and provided a corporate update (Press release, Momenta Pharmaceuticals, AUG 9, 2018, View Source [SID1234528838]).

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"The strategic review of our business announced earlier this year is progressing and we are actively evaluating options for our biosimilars business. We expect to complete this review and announce an outcome in the coming weeks," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Our novel drug candidates for rare autoimmune diseases continue to advance. We remain on track to initiate two Phase 2 proof of concept studies of M281 in the fourth quarter of 2018 and a Phase 1/2 proof of concept study of M254, our hyper-sialylated IVIg candidate, in late 2018 or early 2019, pending regulatory feedback."

Second Quarter Highlights and Recent Events

Complex Generics:

Glatopa Products: a fully substitutable, AP-rated generic version of three-times-a-week COPAXONE 40 mg/mL and daily COPAXONE 20 mg/mL (glatiramer acetate injection) for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

In the second quarter of 2018, Momenta recorded $11.8 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products.

Enoxaparin Sodium Injection: First FDA-approved, substitutable generic LOVENOX (Enoxaparin Sodium Injection) used for the prevention and treatment of deep vein thrombosis developed in collaboration with Sandoz

In June 2018, Sandoz alerted its customers and the U.S. Food and Drug Administration (FDA) that it will be discontinuing the supply of the Enoxaparin Sodium Injection product.

Biosimilars:

M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)

· In January 2018, the Company announced that the Biologics License Application (BLA) for M923 is prepared to be filed with the FDA.

·In June 2018, Momenta announced that it had reached a contract amendment to an agreement with Human Genome Sciences, Inc. ("GSK"), the supplier of product for M923, in which Momenta will pay GSK $15.0 million by August 15, 2018 and $15.0 million by July 1, 2019 as part of Momenta’s contractual commitments for the purchase of product batches for M923 through 2022.

M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with Mylan

·In late 2017, Momenta announced that M834 did not meet its primary pharmacokinetic endpoints in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to investigate these results in order to determine the next steps for the program.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

·In January 2018, Momenta and Mylan disclosed that M710 is a proposed biosimilar to EYLEA and announced an IND acceptance by the FDA. The two companies are in the process of initiating the pivotal clinical trial in patients and the trial is progressing according to plan.

Novel Drugs for Rare Autoimmune and Immune-mediated Diseases:

M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

·Momenta is finalizing its development strategy for M281 and planning two Phase 2 proof of concept clinical trials in the fourth quarter of 2018, pending regulatory feedback.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

·CSL’s Phase 1 study in healthy volunteers to evaluate the safety and tolerability of M230 is ongoing and is targeted to be completed in 2019.

M254 (hsIVIg): a hyper-sialylated immunoglobulin designed to be a higher potency alternative to intravenous immunoglobulin (IVIg) with the potential for enhanced safety and convenience

·The Company has successfully completed the IND-enabling toxicology study of M254 and is targeting the initiation of a Phase 1/2 proof of concept study in late 2018 or early 2019, pending regulatory feedback.

Second Quarter 2018 Financial Results

Revenue: In the second quarter of 2018, the Company recorded $11.8 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products compared to $19.1 million in profit share from Sandoz sales of Glatopa 20 mg/mL for the same period in 2017, net of a deduction of $0.6 million for reimbursement to Sandoz of the Company’s share of Glatopa-related legal expenses. The decrease in product revenues of $7.3 million, or 38%, was primarily due to lower net sales driven by market decline and Mylan N.V.’s entry into the COPAXONE market.

Research and development revenue for the second quarter of 2018 was $1.3 million compared to $4.4 million recorded in the same quarter last year. The decrease in research and development revenue of $3.1 million, or 70%, was primarily due to lower revenue recognized from the Mylan upfront payment as compared to the amount recognized in the 2017 period and lower reimbursable expenses for the Company’s complex generic programs.

Total revenues for the second quarter of 2018 were $13.0 million compared to $23.6 million for the same period in 2017.

Operating Expenses: Total GAAP operating expenses were $83.9 million in the second quarter of 2018.

Research and development expenses for the second quarter of 2018 were $31.3 million, compared to $39.1 million for the same period in 2017. The decrease of $7.8 million, or 20%, was primarily due to a decrease in external R&D expenses for M923 offset by increases in spending for M281 and M230.

General and administrative expenses for the second quarter of 2018 were $22.5 million, compared with $22.6 million for the same period in 2017.

During the second quarter, Momenta entered into a contract amendment to an agreement with GSK, the supplier of product for M923, for which Momenta will pay GSK $30.0 million as

part of Momenta’s contractual commitments for the purchase of product batches for M923 through 2022. The amount has been included in operating expenses for the quarter. As a result, second quarter non-GAAP operating expense was $78.0 million. Excluding the expense associated with the amendment of the M923 agreement, non-GAAP operating expense would be $48.0 million. Momenta previously provided guidance of $45 – $55 million for non-GAAP operating expense for the second quarter. Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Loss: The Company reported a net loss of $69.9 million, or $0.91 per share for the second quarter of 2018 compared to a net loss of $36.9 million, or $0.50 per share for the same period in 2017.

Cash Position: At June 30, 2018, Momenta had $321.2 million in cash, cash equivalents and marketable securities compared to $346.0 million at March 31, 2018.

2018 Financial Guidance

Due to the ongoing strategic review of the business, Momenta’s 2018 operating expense guidance is no longer accurate and may continue to change subject to the outcome of the Company’s strategic review. Momenta plans to provide updated 2018 operating expense guidance for 2018 when it reports its third quarter 2018 financial results.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense and collaborative reimbursement revenues. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company has provided the estimated reconciling information

that is available without unreasonable effort in the section of this press release above entitled "2018 Financial Guidance."

Conference Call Information

Management will host a conference call and webcast today at 8:00 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company’s website, www.momentapharma.com. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 8687156. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through August 16, 2018. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 8687156.