34 unchanged sentences
It is estimated to affect over 30 million people in the United States.
−Removed: We have developed a PL9643 ophthalmic solution (topical eye drops) in a single use delivery device, and a Phase 3 pivotal clinical trial (“MELODY-1”) designed to support a New Drug Application (“NDA”) which is ongoing.
+Added: We have developed a PL9643 ophthalmic solution (topical eye drops) in a single use delivery device, and a Phase 3 pivotal clinical trial (“MELODY-1”) designed to support a New Drug Application (“NDA”) has completed patient enrollment, with top line results expected by December 31, 2023.
An interim analysis by an independent Data Monitoring Committee (“DMC”) of the first 120 patients who had completed the MELODY-1 trial recommended the study continue with a sample size of up to 350 patients.
−Removed: Topline results from the MELODY-1 trial are now expected in the second quarter of calendar 2023.
+Added: Topline results from the MELODY-1 trial are now expected in the fourth quarter of calendar 2023.
Our Phase 2 clinical trial demonstrated improvements in both the signs and symptoms of dry eye disease in moderate to severe patients after just two weeks of treatment, with no adverse safety signals and excellent tolerability.
4 unchanged sentences
We have completed subcutaneous dosing of human subjects in a Phase 1 single and multiple ascending dose clinical safety study, and a human microdose pharmacokinetic study to evaluate a polymer-encapsulated, delayed-release, oral formulation of PL8177.
−Removed: For ulcerative colitis and other inflammatory bowel diseases we will administer PL8177 in our oral formulation to deliver PL8177 to the interior wall of the diseased bowel.
+Added: For ulcerative colitis and other inflammatory bowel diseases we administer PL8177 in our oral formulation to deliver PL8177 to the interior wall of the diseased bowel.
PL8177 activates MC1r present on the interior wall of the bowel in ulcerative colitis and other inflammatory bowel diseases.
We believe that PL8177 at MC1r in the bowel wall will maximize treatment effect while minimizing any systemic or off-target effects.
−Removed: A Phase 2 study in ulcerative colitis using our polymer-encapsulated, delayed-release, oral formulation of PL8177 initiated patent enrollment in September 2022, and may take up to one year to complete.
+Added: A Phase 2 study in ulcerative colitis using our polymer-encapsulated, delayed-release, oral formulation of PL8177 initiated patent enrollment in September 2022, and is ongoing.
The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, adaptive design, parallel group of PL8177 study, with once daily oral dosing in adult ulcerative colitis subjects.
The study uses an adaptive design with an interim assessment by an independent DMC after the initial 16 subjects have completed the 8-week evaluation visit.
+Added: Diabetic Nephropathy Proof-of-Concept Study.
+Added: A Phase 2 proof-of-concept study is currently enrolling patients in a study for diabetic nephropathy.
+Added: Diabetic nephropathy, also called diabetic kidney disease, is the most common cause of end-stage renal disease in the United States and other developed countries.
+Added: A melanocortin pan agonist is administered by subcutaneous injection to patients taking conventional renin-angiotensin-aldosterone system (“RAAS”) inhibitors.
Melanocortin Peptides for Diabetic Retinopathy.
10 unchanged sentences
Palatin assumed Vyleesi manufacturing agreements, and AMAG transferred information, data and assets related exclusively to Vyleesi, including existing inventory.
−Removed: AMAG provided certain transition services to Palatin for a period to ensure continued patient access to Vyleesi during the transition period, for which Palatin reimbursed AMAG for the agreed upon costs of the transition services.
Vyleesi faces competition primarily from Addyi® (flibanserin), which was introduced into the market in October 2015 for the treatment of HSDD in pre-menopausal women and is marketed by Sprout Pharmaceuticals, Inc.
4 unchanged sentences
Vyleesi may also face competition with products prescribed “off-label” by healthcare providers.
−Removed: Gross product sales of Vyleesi increased to $5.8 million in the fiscal year ended June 30, 2022 (“fiscal 2022”), compared to $4.7 million in the fiscal year ended June 30, 2021 (“fiscal 2021”), with gross product sales in the fourth quarter ended June 30, 2022 increasing 79% over the prior quarter and 91% over the comparable quarter in 2021.
−Removed: Net sales of Vyleesi were $1.2 million in fiscal 2022, compared to negative net sales of $0.3 million in fiscal 2021.
+Added: Gross product sales of Vyleesi increased to $12.5 million in the fiscal year ended June 30, 2023, compared to $5.8 million in the fiscal year ended June 30, 2022 (“fiscal 2022”), with gross product sales in the fourth quarter ended June 30, 2023 increasing 20% over the prior quarter and 78% over the comparable quarter in 2022.
+Added: Net sales of Vyleesi were $4.9 million in fiscal 2023, compared to $1.2 million in fiscal 2022.
Vyleesi is distributed nationally through a home delivery specialty pharmacy.
1 unchanged sentence
We also focus our Vyleesi marketing efforts towards healthcare professionals, who play a significant role in increasing HSDD and Vyleesi awareness among their patients.
−Removed: As the commercial potential of Vyleesi is demonstrated, Palatin will explore licensing, marketing and distribution rights for the United States to a marketing partner.
+Added: As the commercial potential of Vyleesi is demonstrated, Palatin is exploring licensing marketing and distribution rights for the United States to a marketing partner.
In early September 2017, we entered into a license agreement with Fosun for exclusive rights to commercialize Vyleesi in China.
41 unchanged sentences
In addition, there are a number of drugs in clinical development for treatment of dry eye disease, with several agents reported to be in or have completed Phase 2 development.
−Removed: Products under development include perfluorohexyloctane, cyclosporine, TRPM8 selective agonist, aldehyde derivative, partial TrkA receptor agonist, cardiolipin peroxidation inhibitor, tumor necrosis factor agonists, alpha-2 adrenergic receptor agonist, calcineurin inhibitors, and nicotinic receptor agonists, among others.
+Added: Products under development include perfluorohexyloctane, cyclosporine, TRPM8 selective agonist, aldehyde derivative, partial TrkA receptor agonist, cardiolipin peroxidation inhibitor, tumor necrosis factor antagonists, alpha-2 adrenergic receptor agonist, calcineurin inhibitors, and nicotinic receptor agonists, among others.
There are no reported MC1r agonist drugs in clinical trials by third parties for dry eye disease.
20 unchanged sentences
We seek patent protection for our technologies and products in the United States and those foreign countries where we believe patent protection is commercially important.
−Removed: We own three issued United States patents and a pending patent application in the United States for methods of treating FSD with Vyleesi, with related patents issued or pending in selected countries in Europe and Asia and in Australia and New Zealand.
+Added: We own four issued United States patents and pending patent applications in the United States for methods of treating FSD with Vyleesi, with related patents issued or pending in selected countries in Europe and Asia and in Australia and New Zealand.
We do not know the full scope of patent coverage we will obtain, or whether any patents will issue other than the patents already issued.
6 unchanged sentences
We have filed patent applications under the Patent Cooperation Treaty claiming PL9643 and other peptides in development for ocular and inflammatory disease indications and have entered national stage prosecution in the United States, European Patent Office, Eurasian Patent Office, and broadly throughout the world.
−Removed: If a patent is granted, the patents will have a presumptive term until 2041.
+Added: If one or more patents are granted, the patents will have a presumptive term until 2041.
Until one or more product candidates covered by a claim of one of these patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments.
204 unchanged sentences
Vyleesi is manufactured using contract manufacturing companies.
−Removed: Pursuant to the termination of the license agreement with AMAG, we have assumed contracts relating to manufacturing, and intend to manufacture Vyleesi for sales in the United States and to our licensees throughout the world.
−Removed: Our PL3994 product candidate is a peptide mimetic molecule, incorporating a proprietary amino acid mimetic structure and amino acids.
−Removed: We have had a contract manufacturer make the active pharmaceutical ingredient in quantities sufficient for Phase 1 and Phase 2.
+Added: Pursuant to the termination of the license agreement with AMAG, we have assumed contracts relating to manufacturing, and manufacture Vyleesi for sales in the United States and to our licensees.
Our MC1r and MCr agonist product candidates are synthetic peptides.
We have had a contract manufacturer make both the PL8177 and PL9643 peptides in suitable scale for toxicity studies and under GMP for clinical trial use.
−Removed: The PL8177 drug product oral formulations for ulcerative colitis has been manufactured for clinical trial use.
+Added: The PL8177 drug product oral formulation for ulcerative colitis has been manufactured for clinical trial use.
While the production process for making peptide active pharmaceutical ingredient involves well-established technology, there are a limited number of manufacturers capable of scaling up to commercial quantities under GMP at acceptable costs.
Additionally, scaling up to commercial quantities may involve production, purification, formulation and other problems not present in the scale of manufacturing done to date.
−Removed: Manufacturing drug product, such as the oral formulation of PL8177, similarly may involve production, formulation and other problems not present in manufacturing at laboratory scale.
+Added: Manufacturing drug product, such as the oral formulation of PL8177, similarly may involve production, formulation and other problems not present in manufacturing at clinical trial or laboratory scale.
The failure of any manufacturer or supplier to comply with FDA regulations, including GMP or medical device quality systems regulations (“QSR”), or to supply the device component or drug substance and services as agreed, would force us or our licensees to seek alternative sources of supply and could interfere with our and our licensees’ ability to deliver product on a timely and cost-effective basis or at all.
20 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.