NORTHBROOK, Ill., May 25, 2021 / PRNewswire / – Today, federal circuit judge William C. Bryson, senior judge of the circuit of the United States Court of Appeals for the federal circuit, appointing the United States District Court for the district of Delaware, granted Clarus’ proposed summary judgment against Lipocine, Inc. (“Lipocine”; NASDAQ: LPCN) for failing to provide an adequate written description of the patent claims asserted by Lipocine. In his decision, which gives Clarus an unequivocal victory, Judge Bryson found all of Lipocine’s claimed patent claims invalid. Clarus’ defense of the unfair conduct, which will be tried before Judge Bryson, remains pending, and his disposition is expected to be addressed by Clarus and the Court at a future date.
Lipocine initiated the patent infringement action against Clarus on April 2, 2019, arising from the marketing of JATENZO by Clarus, an FDA-approved oral testosterone replacement product in March 2019 and launched in March 2020. Lipocine previously dismissed allegations of infringement against Clarus on two other U.S. patents. Lipocins.
“Judge Bryson’s decision is extremely gratifying and completely eliminates claims of Lipocine infringement, which Clarus considered from day one to be without merit,” said Drs. Robert Dudley, Chairman, CEO and Chairman of Clarus. “We thank the Court for its carefully reasoned judgment in favor of Clarus.”
“Clarus focuses on devoting all of our resources to the evolution of medications that allow people to live the best they can every day,” Dr. Dudley added. “With this decision, Clarus continues to move forward with the commercialization of JATENZO and expand its pipeline beyond men’s health.”
About Clarus Therapeutics, Inc.
Clarus is a pharmaceutical company with experience and interest in developing androgenic and metabolic therapies for men and women, including potential therapies for orphan indications. Clarus ’first commercial product, JATENZO, was launched in early 2020. For more information, visit www.clarustherapeutics.com and www.jatenzo.com
Some statements made in this press release are “forward-looking statements” within the meaning of federal securities laws, including statements about the parties’ ability to close the proposed business combination and related transactions, the expected benefits of the combination of proposed business and financial position, results of operations, profit and loss prospects and prospects of Blue Water and / or the proposed business combination and related transactions and may include statements for the period following the completion of the business combination. proposed business and related transactions. In addition, any statements that refer to projections (financial or otherwise), forecasts or other characterizations of future events or circumstances, including the underlying assumptions, are forward-looking statements. Prospective statements are often identified by words such as “plan”, “believe”, “expect”, “anticipate”, “pretend”, “prospect”, “love”, “forecast”, “project”, “continue”, “” could “,” can “,” can “,” possible “,” potential “,” predict “,” should “,” should “and other similar words and expressions, but the absence of such words does not mean that the statement is not prospective.
The forward-looking statements are based on current expectations of the management of Blue Water and Clarus Therapeutics, as applicable, and are inherently subject to uncertainties and changes in circumstances and their potential effects and are only discussed as of the date hereof. statement. It cannot be assured that future developments will be as planned. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied in these forward-looking statements, including: risks related to Clarus Therapeutics ’ability to increase sales. JATENZO, ensures favorable reimbursement coverage for these sales and expands its product offering to include a range of androgenic and metabolic therapies for men and women, including orphan indications; the possibility of completing the proposed business combination and obtaining approval from Blue Water shareholders or meeting other conditions for closing the final merger agreement; the outcome of any legal proceedings that may be initiated against Blue Water or Clarus related to the proposed merger agreement or transaction; the ability to hold the listing of Blue Water on a national stock exchange; the amount of any redemption by existing holders of Blue Water common shares; the ability to recognize the expected benefits of the business combination; other risks and uncertainties included in the “Risk Factors” heading in the registration statement on Form S-4 to be submitted by Blue Water, in Blue Water’s final prospectus for its initial public offering dated December 16, 2020 and in the other Blue Water files in the SEC.
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JATENZO® (testosterone undecanoate) capsules, CIII, are an androgen indicated for testosterone replacement therapy in adult men for conditions associated with endogenous testosterone deficiency or absence:
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, missing testicle syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum levels of testosterone and gonadotropins (follicle stimulating hormone). [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): deficiency of gonadotropin or luteinizing hormone-releasing hormone (LHRH) or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone levels, but have gonadotropins in the normal or low range.
Limitation of use
The safety and efficacy of JATENZO in men under 18 years of age have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED BLOOD PRESSURE
- JATENZO may cause increases in blood pressure (BP) that may increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
- Before starting JATENZO, consider the patient’s basal cardiovascular risk and ensure that blood pressure is properly controlled.
- Periodically monitor and treat new-onset hypertension or exacerbations of pre-existing hypertension, and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease during treatment.
- Because of this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
JATENZO is contraindicated in men with known or suspected breast cancer or prostate cancer. JATENZO is contraindicated in pregnant women, as testosterone can cause damage to the fetus.
WARNINGS AND PRECAUTIONS
- Check the hematocrit before initiation and every 3 months while the patient is on JATENZO and if the hematocrit rises, stop JATENZO until the hematocrit decreases to an acceptable level. If the hematocrit increases after restarting JATENZO, stop permanently.
- Supervise patients with androgen-treated benign prostatic hyperplasia (BPH) due to an increased risk of worsening signs and symptoms of BPH.
- Venous thromboembolic events (VTEs), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products such as JATENZO. Assess patients with signs or symptoms compatible with DVT or PE and, if VTE is suspected, discontinue JATENZO and initiate appropriate treatment and management.
- Testosterone has been abused, usually at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
- Large doses of androgens can suppress spermatogenesis by inhibiting pituitary FSH feedback. Inform patients of this risk before prescribing JATENZO.
- Prolonged use of high doses of methyltestosterone has been associated with severe hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of liver dysfunction and JATENZO should be discontinued while the cause is being assessed.
- Edema, with or without congestive heart failure, can be a serious complication in patients with pre-existing heart, kidney, or liver disease. In addition to discontinuing the medication, diuretic therapy may be needed.
- Gynecomastia can develop and persist in patients treated for hypogonadism.
- Sleep apnea can occur in some patients, especially those with risk factors such as obesity or chronic lung disease.
- Changes in serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor your lipid profile periodically, especially after starting testosterone therapy.
- Use JATENZO with caution in cancer patients at risk of hypercalcemia. Regularly monitor serum calcium levels during treatment with JATENZO in these patients.
- Androgens, including JATENZO, may decrease thyroxine-binding globulin concentrations, resulting in decreased serum T4 concentrations and increased T3 and T4 resin uptake. However, free thyroid hormone concentrations remain unchanged and there is no clinical evidence of thyroid dysfunction.
- Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials.
The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).
These are not all the risks associated with JATENZO. For more information, click here for complete prescription information, including the BOX WARNING on blood pressure increases. You can also find information about Jatenzo at www.jatenzo.com.
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