LLY Scores Win In Alimta Patent Suit, LXRX For The Long Haul, MNKD Breathes Easy

(RTTNews) - Today's Daily Dose brings you news about a District Court's ruling in Lilly's patent suit against Dr. Reddy's Labs; Lexicon Pharma's 52-week data from its type 1 diabetes trial; new data from MannKind's STAT study of Afrezza, and full results from Zafgen's type 2 diabetes study.

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The U.S. District Court for the Southern District of Indiana has ruled in favor of Eli Lilly and Co. (LLY) in the lawsuit against Dr. Reddy's Laboratories related to Alimta (pemetrexed for injection) vitamin regimen patent.

Alimta is approved for the treatment of malignant pleural mesothelioma and locally-advanced and metastatic non-small cell lung cancer. In 2017, Alimta brought home global sales of $2.06 billion for Lilly, including sales of $1.03 billion in the U.S.

A favorable ruling means that the Alimta vitamin regimen patent would be infringed by Dr. Reddy's Labs if it markets alternative salt forms of pemetrexed prior to the patent's expiration in May 2022.

On June 15, 2018, the District Court also ruled in favor of Lilly in the case of Eli Lilly v. Hospira Inc., relating to Alimta patent, denying Hospira's motion for summary judgement and granting Lilly's cross-motion for summary judgement.

Both Dr. Reddy's Laboratories and Hospira are expected to appeal the ruling. LLY closed Friday's trading at $85.92, down 0.17%.

Lexicon Pharmaceuticals Inc. (LXRX) announced 52-week data from its inTandem2 study of Sotagliflozin in adults with type 1 diabetes, on Saturday, which demonstrated statistically significant reductions in A1C levels and weight compared to optimized insulin alone.

The inTandem2 study was a 96-site, European Phase 3 trial that evaluated the safety and efficacy of two different doses of oral Sotagliflozin (200 mg or 400 mg) in combination with optimized insulin compared to optimized insulin alone.

Sotagliflozin 400 mg was associated with a lower incidence of severe hypoglycemia compared to placebo.

The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment, and positive primary endpoint results were reported in December 2016.

Similarly, the North American study of Sotagliflozin, dubbed inTandem1, has also demonstrated statistically significant reductions in A1C levels and weight compared to optimized insulin alone at Week 52.

The inTandem1 study was a 75-site, North American Phase 3 trial that compared the safety and efficacy of two different doses of oral Sotagliflozin (200 mg or 400 mg) in combination with optimized insulin compared to optimized insulin alone.

The primary endpoint of the inTandem1 study, which showed a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin, was reported in September 2016.

Sotagliflozin, developed by Lexicon Pharmaceuticals and Sanofi, with the proposed brand name Zynquista, is under review by the FDA and European Medicines Agency. In the U.S., the regulatory agency's decision on Sotagliflozin is expected on March 22, 2019.

If approved, Zynquista would be the first oral antidiabetic drug approved in the U.S. for use by adults with type 1 diabetes, in combination with insulin, according to the Company.

LXRX closed Friday's trading at $13.58, up 3.90%.

MannKind Corp. (MNKD), on Saturday, announced new data for Afrezza from its STAT study.

The STAT study, which compared Novo Nordisk Inc.'s (NVO) insulin Aspart versus Afrezza in patients with type 1 diabetes on multiple daily injections, is the first MannKind study to include and prospectively evaluate the use of continuous glucose monitoring with Afrezza therapy.

The dual primary endpoints were assessment of glucose time-in-range as well as *post-prandial glucose excursions in the 1-4 hour post-meal period. (*Postprandial glucose excursion (PPGE) is defined as the change in glucose concentration from before to after a meal).

The new STAT data demonstrated that Afrezza dosed before and (as needed) after meals significantly improved all-day glucose time-in-range, limited daytime glucose variability and significantly reduced the overall rate and time spent in hypoglycemia.

Hypoglycemia, also known as low blood sugar, is one of the major limiting factors of insulin therapy. However, the use of Afrezza has found to be associated with significantly lower rates of hypoglycemia in Type 1 diabetes patients across a wide range of HbA1c as compared to insulin Aspart.

Afrezza was approved to treat diabetes in the U.S. in June 2014. For the first quarter of 2018, Afrezza net revenue was $3.4 million compared to $1.2 million in the year-ago quarter.

MNKD closed Friday's trading at $2.01, up 2.55%.

Processa Pharmaceuticals Inc.'s (PCSA.OB) lead drug candidate PCS499 has been granted orphan-drug designation by the FDA for treatment of Necrobiosis Lipoidica (NL).

Necrobiosis Lipoidica (NL) is a chronic, disfiguring skin condition, characterized by collagen degeneration, granuloma formation, fat deposition, and endothelial wall thickening.

The Company plans to begin clinical studies of PCS499 in Necrobiosis Lipoidica this year.

PCSA.OB closed Friday's trading at $4.00, up 2.56%.

Zafgen Inc. (ZFGN), on Saturday, announced positive full results from its phase II clinical trial of ZGN-1061 in patients with type 2 diabetes.

There was a statistically significant reduction in A1C with ZGN-1061 0.9 mg versus placebo at Week 8 and Week 12. The compound also demonstrated a favorable safety and tolerability profile, with no treatment-related serious adverse events or CV safety signals.

Additionally, the Company reported supportive nonclinical data for ZGN-1061, including data on combination treatment with ZGN-1061 and liraglutide, and data on treatment with ZGN-1061 in nonalcoholic steatohepatitis (NASH).

The nonclinical data on treatment with both ZGN-1061 and liraglutide suggest that this combination therapy may yield additive improvement in glycemic control and weight loss.

In a NASH model, ZGN-1061 markedly reduced liver weight, NAS score and markers of liver damage (ALT and AST), added the Company.

ZFGN closed Friday's trading at $7.09, up 5.66%.